Tag Archives: FDA

The Associated Press reports: Gay and bisexual men in monogamous relationships can donate blood in the U.S. without abstaining from sex, under a federal policy finalized Thursday by health regulators. The Food and Drug Administration guidelines ease decades-old restrictions designed to protect the blood supply from HIV. The agency announced plans for the change in January and said this week …

The New York Times reports: A panel of advisers to the Food and Drug Administration voted unanimously on Wednesday that the benefits of making a birth control pill available without a prescription outweigh the risks, a significant step in the decades-long push to make oral contraception obtainable over the counter in the United States. If the F.D.A. approves nonprescription sales …

CBS News reports: Do you like taking your dog to restaurants? Go ahead, it’s fine, according to the Food and Drug Administration which now says it’s safe to bring dogs to restaurants with outdoor seating. The new guidance came in an update to the 2022 FDA food code. The FDA stated that its health rules “allow for pet dogs in …

Gothamist reports: Consumer Reports is pushing for the removal of Red Dye No. 3 from multiple Peeps candies — saying the ingredient is a carcinogen — days ahead of Easter and peak Peep season. Several Peeps products — including Pink Marshmallow Chicks, Easter Marshmallow Pink Bunnies and Easter Marshmallow — contain the ingredient, which has been debated for decades over …

The New York Times reports: Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter, the Food and Drug Administration said on Wednesday, authorizing a move long-sought by public health officials and treatment experts, who hope wider availability of the medicine will reduce the nation’s alarmingly high drug fatality rates. By late summer, over-the-counter …

Reuters reports: On at least four occasions since 2019, Elon Musk has predicted that his medical device company, Neuralink, would soon start human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness. Yet the company, founded in 2016, didn’t seek permission from the FDA until early 2022 – and the agency rejected the application, seven current …

Via press release: Today, the U.S. Food and Drug Administration announced that it has taken action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country to address a growing public health concern. The chemical xylazine has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs …

CBS News reports: Some of the biggest makers of cereals, frozen and packaged food have submitted dozens of claims to the Food and Drug Administration objecting to new rules that would exclude food with high amounts of added sugar and salt from being labeled as “healthy” on packaging. Some manufacturers have even called the regulations unconstitutional, saying they violate companies’ …

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test …

The Associated Press reports: Soy, oat, almond and other drinks that bill themselves as “milk” can keep using the name, according to draft federal rules released Wednesday. Food and Drug Administration officials issued guidance that says plant-based beverages don’t pretend to be from dairy animals – and that U.S. consumers aren’t confused by the difference. Dairy producers for years have …

The Associated Press reports: Gay and bisexual men in monogamous relationships will no longer be forced to abstain from sex to donate blood under federal guidelines to be proposed in coming days, ending a vestige of the earliest days of the AIDS crisis. The planned relaxation of restrictions by the Food and Drug Administration follows years of pressure by blood …

NPR reports: The Food and Drug Administration is considering a major shift in the nation’s COVID-19 vaccine strategy. The goal is to simplify vaccination against COVID and perhaps adopt an approach similar to what is used for the flu vaccine, with annual updates to match whatever strain of the virus is circulating. Currently, people who want to be fully vaccinated …

The Wall Street Journal reports: A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. …

Axios reports: The Food and Drug Administration is weighing a series of moves to make it easier for gay and bisexual men and other individuals to donate blood amid a nationwide blood shortage. The FDA is considering easing blood donor screening restrictions for men who have sex with men that originated during the HIV/AIDS crisis in the 1980s. An option …

Reuters reports: Major U.S. retailers will begin selling lower-cost hearing aids without a prescription or medical exam under final Biden administration rules that take effect Monday. The Food and Drug Administration (FDA) in August approved the sale of over-the-counter hearing aids, allowing millions of Americans to buy hearing aids without seeing an audiologist and potentially saving individuals thousands of dollars. …

The Hill reports: The Food and Drug Administration (FDA) is warning young people against engaging in an online trend that challenges people to cook with over-the-counter drugs, saying there are “significant risks” in using these medications incorrectly. At the beginning of this year, the trend took off on social media apps such as TikTok, where users would post videos of …

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores …

The Washington Post reports: Biden administration officials are set to announce Tuesday a new strategy to split monkeypox vaccine doses in hopes of vaccinating up to five times as many people against the virus, according to officials with direct knowledge of the plan. Rather than inject doses of Jynneos subcutaneously, a traditional way of delivering vaccines into the fatty tissue …

CNBC reports: The U.S. will make 786,000 additional monkeypox vaccine doses available to local health departments “as soon as possible” after the Food and Drug Administration approved the shots for distribution. The Jynneos vaccine is made by the Danish biotech company Bavarian Nordic. The FDA had to inspect and sign off on a Bavarian Nordic plant in Denmark to ensure …

The Associated Press reports: The U.S. government has purchased more than 1.1 million completed doses of the vaccine produced by Bavarian Nordic in Denmark. But the company said earlier this week it needed authorization from an on-site FDA inspection before it could begin sending most of them to the U.S. An FDA spokeswoman said late Wednesday that regulators “expedited and …