As of March 17, 2020, thousands of movie theaters across the United States will be closing until further notice because of the coronavirus pandemic. They join the thousands of other cinemas around the world that have also shut down for the same reasons.
AMC Theatres, Regal Cinemas, Cinemark and Cineplex are closing until further notice all of their locations in the United States. Cinemark is closing as of March 18, 2020, while the other major cinema companies are closing as of March 17, 2020. In the U.S., several independent movie theaters, such as Alamo Drafthouse and Landmark, also closed of all their locations. In some cities and states, these closures are mandatory. In other areas, the closings are voluntary.
Refunds are being given for tickets purchased in advance for screenings that will no longer take place. AMC, Regal and Alamo Drafthouse all have subscription services. As of this writing, only AMC has officially announced that it will not charge subscription fees during the period of time that its theaters are closed, although Regal and Alamo Drafthouse will no doubt have similar policies. AMC also announced that its subscriptions expirations will not be in effect during the closure of AMC Theaters.
Other movie-theater chains in North America that have closed until further notice include Marcus Theatres, Harkins Theatres, B&B Theatres, National Amusements (also known as Showcase), Caribbean Cinemas, Goodrich Quality Theaters, Southern Theatres, Cinépolis Luxury Cinemas, Neighborhood Cinema Group and Georgia Theatre Company.
Most of the movie theaters in the U.S. that are remaining open have pledged to not book theater rooms at more than 50% capacity. But given the huge dropoff in moviegoing since the coronavirus outbreak was classified as a pandemic, attendance at movie theaters was reaching well below 50% anyway.
In the United Kingdom and Ireland, the three largest cinema companies—Cineworld, Odeon and Picturehouse—are also closing all of their locations, as of March 17, 2020, in Ireland and as of March 18, 2020, in the United Kingdom. These shutdowns will continue until further notice.
What does this mean for movie audiences? Major studios are shortening the period of time that movies in theatrical release will be released on home video for rental or purchase. Universal Pictures has already announced that it will release DreamWorks Animation’s “Trolls World Tour” on video on demand (VOD) and in theaters on April 10, 2020. “Trolls World Tour” had previously been scheduled for theatrical release only on that date. Other movies that are currently in theatrical release will have their home-video releases moved up.
The industry standard used to be that major studios would wait at least 90 days before a movie in theatrical release would be released on home video or streaming services. (This rule wasn’t followed by most independent studios.) The major studios would be threatened with boycotts by corporate-owned movie theaters if they didn’t comply with this 90-day window. And it’s why corporate-owned theaters such as AMC, Regal, Cineplex and Cinemark would not carry independent films and films from streaming services that didn’t follow this release mandate.
But now, with almost all of these corporate-owned movie theaters closed until further notice, they no longer have the power to dictate when studios can release films on home video after a theatrical release. The power has now shifted to those who can deliver movies to people in ways that don’t involve movie theaters. Going to the movie theaters won’t be considered obsolete, but the coronavirus pandemic has permanently altered the cinema business. It’s going to take a very long time for movie theaters to recover. Going to movie theaters just won’t reach the same levels that it had during its peak.
Click here for an updated list of other corona virus-related cancellations and postponements in the entertainment industry.
June 19, 2020 UPDATE: The three biggest cinema companies in the U.S. have announced their re-opening dates:
Regal Cinemas: July 10, 2020
AMC Theatres: July 15, 2020
Cinemark: July 17, 2020
Regal and AMC have announced that they will require all employees and customers to wear masks in the theater building. Customers who show up without masks can purchase masks at the theater location. Cinemark will require all employees to wear masks but will not require customers to wear masks in states or cities that do not have policies requiring that people wear masks in public.
In addition, most movie theaters have pledged to not book screening rooms above 50% capacity. Customers will be encouraged to purchase their tickets online or at kiosks instead of at a theater box office. In addition, placing advance online orders for food is also being encouraged. The major cinema companies have also announced stricter guidelines for more frequent cleaning and social distancing inside each theater location’s building.
October 5, 2020 UPDATE: Cineworld, the company that owns Regal Cinemas and Picturehouse, has announced that, for the second time in 2020, it is temporarily closing all of its U.S. theater locations. The temporary closures begin on October 8, 2020. In addition, all Cineworld and Picturehouse location in the United Kingdom will also temporarily close, as of October 8, 2020. The reason cited is the lack of blockbuster movies scheduled for release in 2020. It has not been announced yet when these Regal Cinemas, Cineworld and Picturehouse locations will re-open.
March 20, 2021 UPDATE: Regal Cinemas will re-open on April 2, 2021.
Culture Representation: Taking place in the Los Angeles area, Atlanta, New York City, Brazil and Spain, the documentary “Pornstar Pandemic: The Guys” features a predominantly white group of men (with one African American and one Latino) who work in adult entertainment, doing non-sexual videoconference interviews about how their lives have changed since the COVID-19 pandemic.
Culture Clash: Most of the men talk about how they deal with online haters, crazy fans and misperceptions about men who do gay porn for a living.
Culture Audience: Fans of these adult entertainers are obviously the target audience of “Pornstar Pandemic: The Guys,” but the documentary might also appeal to people who are curious about how the COVID-19 pandemic is affecting people who work in porn.
Dante Colle in “Pornstar Pandemic: The Guys” (Photo courtesy of Breaking Glass Pictures)
The first thing that people need to know about the documentary “Pornstar Pandemic: The Guys” is that it has absolutely no sexual activity and no frontal nudity. “Pornstar Pandemic,” although it has a very catchy title, is basically a very tame interview documentary where male adult-film performers (some more famous than others) are shown in friendly videoconference calls talking about how they’re handling the coronavirus pandemic since the pandemic shut down filming of anything where social distancing is not possible. The interviewees, who do mostly gay porn, also give tours of their homes and show some of their socially distant outdoor activities. The only nudity in the film is when one of the porn stars (Dante Colle) is seen taking a shower and his backside is briefly shown.
If that’s not sexually interesting enough for viewers, there are plenty of places online to see these performers doing sexual activities on camera. But if you’re curious to see what their personalities and lives are like when they’re in semi-quarantine, then “Pornstar Pandemic” might be worth checking out if you know that this movie about porn stars doesn’t have any porn in it.
However, the running time for the movie is a little too long (132 minutes), and boredom might set in quickly for people who are expecting a lot of raunchy talk. There’s hardly anything in the documentary that would be considered sexuality explicit dialogue. It’s a very mainstream, non-pornographic film, but that doesn’t mean the movie is appropriate for everyone.
Longtime adult-film director/producer Edward James “EJ” directed “Pornstar Pandemic: The Guys” as his first mainstream documentary feature. Most of the job is in the editing, because the movie is really just a series of videoconference segments, mostly moderated by adult-film performers Alter Sin (who’s from Spain), Alex Lecomte (from Brazil) and Jack Loft (from the United States).
The movie begins with Sin and Lecomte interviewing Loft at the partially furnished home that Loft shares in Atlanta with his manager, who is not interviewed or seen in the movie. Loft, Sin and Lecomte together then do individual interviews with Colle, Pierce Paris, Elijah Wilde and DeAngelo Jackson. And then, at the end, EJ (who is not seen on camera) interviews Loft, Colle, Paris, Wilde and Jackson. All of them say that their families and friends know that they do porn for a living. They also say that cyberbullying and criticism are unavoidable on social media, and it’s best not to fall into the trap of believing all the harsh things that people say.
In this documentary, Loft is one of the newcomers to porn. He talks about how the coronavirus pandemic shutdown happened soon after he filmed just one porn scene, after moving to Atlanta from a small town in Iowa. Loft (who looks like he’s in his early 20s, and whose physical appearance would put him in the “twink” category) says of his choice to do porn for a living: “I’ve never been the type of person who thinks sex work or pornography was something to be ashamed of.” He adds that “every gay guy” he knows is on Only Fans and/or watches porn.
Loft also says that his family and friends know about his decision to do porn, and they’re okay with it. He believes that for people in his generation (Generation Z), taking naked selfie photos and making consensual sex videos are less taboo than it is for previous generations. He also believes that in the future, there won’t be as big of a stigma for this type of activity as there is now. “Ten years from now, there’s less of a chance of someone trying to use my adult films and my adult pictures against me. In 10 years, I hope it won’t be a big deal.”
This is where Loft shows a major blind spot when it comes to gender, because he doesn’t really seem to understand that when it comes to posing for pornographic photos or doing sex videos, men get a lot less negative reactions and society shaming for it than women do. Loft is also openly gay, so any videos of him having sex with a man wouldn’t be as shocking as it would be if he were a man who presented himself as straight in his personal life.
There are many variables in how porn stars’ sex work will affect their futures, but women who’ve done porn in the past definitely have a harder time overcoming the stigma that comes with it. For example, “Million Dollar Listing New York” reality star Fredrik Eklund, a real-estate agent who is openly gay, has freely admitted to making gay porn videos in his past. Would a woman in the same circumstances be given the opportunity to star in an internationally televised American reality show? At this time, realistically? No. The double standard is real, and it’s not going away anytime soon.
Loft also says that he’s noticed that since the pandemic, people are spending more time online but also being more authentic with their feelings when they’re online. If he’s able to become a more well-known porn actor, he says his two biggest fears are that we won’t look good-enough on camera and that he’ll be misunderstood as disrespectful or inauthentic.
Just like the other performers interviewed in the documentary, Loft says he’s been focusing more on his online activities as a way to make money. And working and staying in shape is obviously a huge priority for all of the actors who are interviewed. It goes without saying that the pandemic doesn’t stop these performers from doing “solo” videos.
Colle (who lives in a small trailer in Malibu, California) says the pandemic has given him more time to work on content for his videos that people can access by subscription or pay-per-view. Colle, who says he doesn’t want to label his sexuality, comments that he’s lucky that his parents have been completely accepting of him doing porn. He also talks about the misconceptions that people have about men who enjoy having sex with men and women. Colle mentions that gay people can be just as prejudiced as straight people who think that sexuality means that you have to choose one gender to be attracted to sexually.
He also shares some stories about what some crazy fans will do to get him to notice them. He says that he uses his parents’ address as his mailing address, so they sometimes get some very kinky mail. Colle also mentions that because he learned from his parents to be smart about saving his money (maybe that’s why he lives frugally in a tiny trailer instead of a house or apartment), he says that he’s not financially panicking during the pandemic, unlike many people he knows who lost their incomes and are running out of money because of the pandemic.
Colle shows some of his workout routine. He also admits that since the pandemic, he doesn’t shower every day, and sometimes he’ll go up to three days without showering. And in case anyone cares, Colle has two very adorable French bulldogs, who make an appearance in his individual interview segment.
Speaking of cute pets, Paris (who lives in Los Angeles) shows two kittens that he’s fostering and plans to adopt. Paris says his hometown is Bozemon, Montana, where he used to be a farm worker. He opens up a little about his high-school days, by saying that he was sort of a “class clown” who got along with various cliques in his school.
And he says that the he’s had a “fetish” for anal sex ever since he first heard a gym teacher mention it in a high-school sex education class. Just like Colle, Paris says he’s open to having sex with men and women in his personal and professional lives, but on camera, Paris is mostly known for having sex with men.
Paris also says that he got inspired to do porn by a TV show (which he does not name) that had crazy sports stunts. He admits that his income has dropped because of the pandemic, but he’s doing more solo videos and his fans like to see his “naked workouts.” He adds, “That’s what’s keeping me busy and making me money.”
When asked how he prepares for doing a porn scene, Paris says that he’s found that he has to spend at least 45 minutes before doing a scene to get mentally and physically ready. He mentions that if he just nonchalantly shows up on the set without that preparation, it has a negative effect on his performance.
Wilde is fairly new to porn, compared to most of the others in this documentary. Currently living in New York City, he says in the documentary that he was born in Montreal but grew up in New York. He used to by a gym trainer as a day job, but due to the pandemic, he lost his gym job. Wilde also says that, as a former go-go dancer, he especially misses going to nightclubs, dancing, and being able to hug his friends.
DeAngelo Jackson, who identifies as gay and lives in Atlanta, is one of the veterans in this documentary’s group of performers. He’s been doing porn since 2008. He says that he lost his virginity in a porn scene, and he describes that experience as “traumatizing.” Unlike the other people interviewed in this documentary, Jackson says his strict and religious family has difficulty accepting that he does porn for a living.
His father was in the military, so Jackson says that he grew up as an “Army brat” in various countries and learned to appreciate different cultures. He also says that when he’s not performing, he’s an “introvert.” There’s a scene in the documentary of Jackson playing a video game wearing very skimpy brief underwear that leaves nothing to the imagination.
At the 2020 GayVN Awards (the Oscars of gay porn), Jackson became the first person of color to win the Best Actor award. He says he’s humbled by the prize, but he also understands that winning the award is something bigger than him, because it’s symbolic of breaking a racial barrier in the porn industry.
He also hopes the prize means that more people will look at black men in porn as not just a “fetish” but award-worthy actors. Wilde, who is also a person of color, mentions toward the end of the documentary that he hopes to follow in Jackson’s footsteps, but Wilde says that would just be happy to be nominated for any award.
When asked for his advice on what he would tell men who are new to porn, Jackson replies: “Know who you are,” because he’s seen too many young men in their late teens and early 20s get “lost” and overwhelmed in adult entertainment because they don’t have a strong sense of identity. Jackson also echoes what some of the other performers say in the documentary: Be professional and treat it like a regular job.
Except it’s not like a regular job. Some of the men interviewed in the film say that their parents and other family members express concerns that they will get HIV or AIDS in their line of work. This is an issue that seems to make porn actors very defensive, because porn actors say that the people they work with in porn are regularly tested for HIV and other STDs, and that it’s actually “safer” to do porn than to have sex with random people who aren’t tested.
One thing that all of these men have in common is that at the time of this filming this documentary, they didn’t talk about being in any committed relationships, past or present, although Colle says dating someone who also does porn is sometimes easier than dating someone who doesn’t do porn. And none of them admitted to having sex during the pandemic, although it’s kind of hard to believe that they’re all celibate during the pandemic. But based on what’s implied in the documentary, even without the pandemic, what they do for a living makes it challenging to have a long-term, committed relationship with a love partner.
Ultimately, “Pornstar Pandemic: The Guys” is a very simply made documentary that can serve as a time capsule of how some male porn stars were living during the first few months of the coronavirus pandemic. (This movie was obviously filmed before June 2020, because director JR says in the documentary that movie production should return to normal by June 2020, but that ended up not happening.) People who are expecting sexually explicit content in the documentary will have to look elsewhere. This movie is really a series of interesting, but not particularly fascinating, conversations to show a more human side to some current and aspiring male porn stars.
Breaking Glass Pictures released “Pornstar Pandemic: The Guys” on DVD and digital on July 28, 2020.
The following is a press release from the U.S. Food and Drug Administration:
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
The U.S. Food and Drug Administration (FDA) issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency’s response efforts.
As part of continued action to protect the American public, the FDA is warning consumers and health care professionals about hand sanitizer products that contain methanol (a.k.a. wood alcohol), a substance often used to create fuel and antifreeze. Methanol is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has seen an increase in hand sanitizer products that are labeled as containing ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death.
Testing updates:
To date, the FDA has currently authorized 162 tests under EUAs; these include 136 molecular tests, 25 antibody tests, and 1 antigen test.
The following is a press release from the U.S. Food and Drug Administration:
The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:
Today, FDA launched the first “FDA Insight” podcast, featuring FDA Commissioner Stephen Hahn, M.D., and FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D., discussing FDA’s COVID-19 efforts, including the drug development process for a COVID-19 treatment. Future FDA Insight podcasts will feature Hahn, Shah, and other FDA leaders’ insights into issues facing the agency — including the COVID-19 pandemic and other emerging topics.
FDA Commissioner Stephen Hahn, M.D., spoke at the German Marshall Fund’s Brussels Forum 2020. This 15th edition of the forum, live-streamed/posted on YouTube, featured a 25-minute conversation with Dr. Hahn, moderated by Axios Health Care Editor Sam Baker.
Today, U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen Hahn, M.D., issued the following joint USDA-FDA statement regarding food export restrictions pertaining to COVID-19:
The United States understands the concerns of consumers here domestically and around the world who want to know that producers, processors and regulators are taking every necessary precaution to prioritize food safety especially during these challenging times. However, efforts by some countries to restrict global food exports related to COVID-19 transmission are not consistent with the known science of transmission.
There is no evidence that people can contract COVID-19 from food or from food packaging. The U.S. food safety system, overseen by our agencies, is the global leader in ensuring the safety of our food products, including product for export.
Testing updates:
To date, there are 149 currently-authorized tests under EUAs; these include 125 molecular tests, 23 antibody tests, and 1 antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The following is a press release from the U.S. Food and Drug Administration:
The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:
Today, FDA revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. The agency issued a Press Release and posted FAQs about this action.
Today, FDA is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended, as it may result in reduced antiviral activity of remdesivir. The agency issued a Press Release about this action.
On June 12, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia.
The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
To learn more about keeping your pets safe during the coronavirus (COVID-19) pandemic, watch this new video.
Testing updates:
To date, the FDA has authorized 138 tests under EUAs, which include 117 molecular tests, 20 antibody tests, and 1 antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The FDA issued a guidance, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.” The guidance addresses questions FDA has received concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency. The guidance explains that, on a temporary basis, the FDA does not intend to object to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional, and the guidance describes the agency’s current policy regarding the signature required at time of delivery of drug samples, to promote public health.
On June 8, 2020, the FDA added the BioMedInnovations SuppleVent Ventilator to the list of ventilators authorized under the March 24, 2020, EUA for certain ventilators, ventilator tubing connectors, and ventilator accessories. This ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes use in an intensive care unit or other hospital environments such as during intra-hospital transport and in temporary hospital facilities. Lawrence Livermore National Laboratory collaborated in the design of the ventilator.
FDA published two new web pages to help the public access information: (1) Innovation to Respond to COVID-19 provides an overview of FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible and (2) Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work.
Testing updates:
To date, the FDA has authorized 125 tests under EUAs, which include 107 molecular tests, 17 antibody tests, and 1 antigen test.
Media Contact:[email protected], 240-402-6386 Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The FDA issued a guidance, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.” The guidance addresses questions FDA has received concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency. The guidance explains that, on a temporary basis, the FDA does not intend to object to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional, and the guidance describes the agency’s current policy regarding the signature required at time of delivery of drug samples, to promote public health.
On June 8, 2020, the FDA added the BioMedInnovations SuppleVent Ventilator to the list of ventilators authorized under the March 24, 2020, EUA for certain ventilators, ventilator tubing connectors, and ventilator accessories. This ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes use in an intensive care unit or other hospital environments such as during intra-hospital transport and in temporary hospital facilities. Lawrence Livermore National Laboratory collaborated in the design of the ventilator.
FDA published two new web pages to help the public access information: (1) Innovation to Respond to COVID-19 provides an overview of FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible and (2) Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work.
Testing updates:
To date, the FDA has authorized 125 tests under EUAs, which include 107 molecular tests, 17 antibody tests, and 1 antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The following is a press release from the U.S. Food and Drug Administration:
The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:
The agency issued a new FDA Voices, titled Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety, and bylined by Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response. In March, the FDA was a few days away from announcing the release of the New Era of Smarter Food Safety Blueprint when the FDA’s focus turned to the COVID-19 pandemic. Plans for the New Era initiative were rightfully put on hold in order to prioritize the agency’s COVID-19 response. The FDA will release the blueprint in the coming weeks, outlining plans over the next decade to create a more digital, traceable, and safer food system.
The FDA added a second ventilator developed by NASA to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA) that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored to provide respiratory support for COVID-19 patients who are experiencing respiratory failure or insufficiency. Where the first NASA ventilator relied on wall gas as the pressure source, the second ventilator uses an internal compressor for its energy source. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators.
The FDA added an emergency resuscitator for the Fitbit Flow to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA). The Fitbit Flow is a continuous respiratory support system that includes an FDA-cleared Manual Resuscitator. The accessory is an AMBU bag with audible and visual alarms that aid the performance of the manual resuscitator for continuous breathing. This design is intended for use in treating patients with COVID-19.
The FDA, in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of pediatric product development plans for the treatment and prevention of COVID-19. In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP).
The FDA recognizes the vital role of health professionals in the fight against COVID-19. In order to help health professionals quickly and easily access FDA resources, we created a new web page, titled Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals. This page contains links to FDA emergency use authorizations; information about personal protective equipment and other medical products for use during COVID-19.
Testing updates:
During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 119 tests under EUAs, which include 103 molecular tests, 15 antibody tests, and 1 antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The following is a press release from the U.S. Food and Drug Administration:
The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:
FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. FDA MyStudies is now referred to as COVID MyStudies in the Apple App store and in the Google Play store.
As part of the FDA’s efforts to protect consumers, the agency issued warning letters to two companies for selling fraudulent COVID-19 products. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
The first seller to whom FDA sent a warning letter was Quadrant Sales & Marketing, Inc., which offers non-alcohol-based hand sanitizer products for sale in the United States with false or misleading claims including that the products maintain their effectiveness for up to 24 hours. Time-specific extended efficacy claims may give users the false impression that they need not rigorously adhere to interventions such as social distancing and engaging in good hygienic practices that have been demonstrated to curb the spread of COVID-19.
The second seller to whom FDA sent a warning letter was StayWell Copper Products, which offers copper “Germ Stopper” products for sale in the United States with misleading claims that the products are safe and/or effective for the prevention of COVID-19.
Today, the FDA took steps to further support the development of COVID-19 tests for at-home self-collection by providing on its website a template that may be used to facilitate submission of requests for emergency use authorizations (EUA) for at-home sample collection kits. As explained in FDA’s guidance, Policy for COVID-19 Tests During the Public Health Emergency (Revised), this template reflects FDA’s current thinking on the data and information that developers should submit to facilitate the EUA process. In particular, this template includes recommendations for use by laboratories and commercial manufacturers who may choose to use it to facilitate the preparation and submission of an EUA request. Currently, developers can offer a COVID-19 test for at-home self-collection where specifically authorized under an EUA or as part of an Institutional Review Board (IRB)-approved study.
Testing updates:
During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 114 tests under EUAs, which include 101 molecular tests, 12 antibody tests, and 1 antigen test.
The following is a press release from the U.S. Food and Drug Administration:
The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:
The FDA issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
The first seller warned, Noetic Nutraceuticals, offers CBD products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
The second seller warned, The Golden Road Kratom, offers kratom products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
The Agency issued a new FDA Voices titled, COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products. It provides details on the FDA’s work to ensure the safety and security of the U.S. supply of food and medical products. Many of the medical products our health care workers and hospitals need to battle COVID-19 come from overseas, which makes the FDA’s Office of Regulatory Affairs (ORA) work imperative to ensure legitimate products are moving as quickly as possible through the ports of entry. At the same time, ORA imports staff also screens for, and blocks the entry of, unproven products that falsely claim to prevent, diagnose, treat or cure COVID-19.
Over the weekend, FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit, the first standalone at-home sample collection kit that can be used with certain authorized tests. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit.
Last week, the FDA approved another Abbreviated New Drug Application for Hydroxychloroquine Sulfate Tablets USP, 200 mg for the treatment of: (1) Uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. (2) Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and (3) Treatment of acute and chronic rheumatoid arthritis in adults. Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events, and hypoglycemia. The FDA recently posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis.
Testing updates:
During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 103 tests under EUAs, which include 90 molecular tests, 12 antibody tests, and 1 antigen test.
