EXPLAINED: 19 | Rare Historical Photos

Michael Hiltzik: In blow to public health, judge tosses FDA lawsuit targeting a clinic offering unproven stem cell treatments

A federal judge in Riverside, California, declared a stem cell treatment firm operating in the state to be exempt from Food and Drug Administration regulations, opening the door to the further proliferation of clinics offering therapies the FDA says are scientifically unproven and potentially dangerous.

Los Angeles Times · Aug 31, 2022

Bluebird bio Seeks Back-to-Back Nods, 'Go' or 'No-Go' For Revance's Botox Rival, Amylyx' Twin Hurdles And More: September's Key PDUFA Catalysts Biotech Investors Must Know

After August’s mixed tally for Food and Drug Administration approvals, investors turn to a new month, which has a fairly loaded calendar.

Benzinga · Aug 31, 2022

FDA greenlights new COVID-19 booster despite limited data - Roll Call

The Food and Drug Administration granted emergency authorization to Pfizer and Moderna for updated COVID-19 booster shots.

Roll Call · Aug 31, 2022

Congressman’s wife died after taking herbal remedy white mulberry leaf marketed for weight loss, diabetes

“Many people assume if that product is sold in the United States of America, somebody has inspected it, and it must be safe,” U.S. Sen. Dick Durbin, D-Ill., said when he introduced legislation to strengthen oversight of dietary supplements. “Unfortunately, that’s not always true.”

Chicago Sun-Times · Aug 25, 2022

US House panel slams Trump’s COVID response; report mentions early role from Mehmet Oz

Mehmet Oz’s advocacy for the drug hydroxychloroquine in the early days of the COVID-19 pandemic is cited in a new congressional report that accuses former President Donald Trump’s administration of pressuring the Food and Drug Administration to endorse unproven treatments and vaccines.

The Philadelphia Inquirer · Aug 24, 2022

Advocates urge FDA action to ease policing fears in menthol ban

WASHINGTON — Experts and advocates are calling on the Biden administration to do more to avoid potential confrontations between police and racial minorities if the Food and Drug Administration finalizes a ban on menthol cigarettes.

Tribune News Service · Aug 24, 2022

What Mayo Clinic experts want you to know about over-the-counter hearing aids

The Food and Drug Administration has cleared the way for the sale of over-the-counter hearing aids, making it possible for consumers to purchase these instruments without medical exams or fittings as soon as this fall. It will likely mean cost savings, but what should those with hearing issues know before…

Tribune News Service · Aug 24, 2022

Over-the-counter hearing aids have been greenlighted by the FDA – your local pharmacist will soon be able to sell you the device you need

After a long delay, the Food and Drug Administration issued final regulations Aug. 16, 2022, for over-the-counter hearing aids. The final rule is effective 60 days from its publication, meaning that consumers could see OTC hearing aids hitting the shelves of community pharmacies nationwide by October 2022.

The Conversation · Aug 23, 2022

Hearing aids OK’d for over-the-counter sale starting in October, prices expected to fall

The Food and Drug Administration said the new regulation creates a new class of hearing aids that don’t require a medical exam or prescription. They’ll be sold online or over-the-counter at pharmacies and other stores.

Chicago Sun-Times · Aug 19, 2022

FDA finalizes over-the-counter hearing aid rule

WASHINGTON — The Food and Drug Administration on Tuesday finalized a rule making hearing aids for people with mild to moderate hearing loss available without requiring them to see a doctor.

Tribune News Service · Aug 16, 2022