How much did you pay to have your brand/product FDA approved? There’s a niche I’m looking to make a brand from. Seems like I need FDA approval even if the factory is (as I’m selling under my LLC). Those going through FDA registrations, how much did it cost and mostly how much time did it take? submitted by /u/Tragilos

Pixel Watch 3 gets FDA clearance for Loss of Pulse alerts Google just announced it’s received FDA clearance for the Pixel Watch 3’s Loss of Pulse Detection feature. It will start rolling out to US devices sometime at the end of March. The Loss of Pulse Detection feature is exactly what it sounds like: if the Pixel Watch 3 senses that you’ve lost your pulse through

Shares of Hims & Hers tumble 26% after FDA says semaglutide is no longer in shortage Shares of Hims & Hers tumble 26% after FDA says semaglutide is no longer in shortage

Susan F. Wood, Who Resigned From the F.D.A. Over Plan B, Dies at 66 She left the agency because of its delay in approving the morning-after pill for over-the-counter use. Her resignation drew national attention.

Do i need to register with the fda Hello everyone, I was wondering if I plan to start a Shopify store in the states and sell prescription eye glasses, would i need to register with the fda and pay the fee? Thank you! submitted by /u/Stunning-Variety-298

RFK Jr.’s Lawyer Has Asked the FDA to Revoke Polio Vaccine Approval Aaron Siri, who specializes in vaccine lawsuits, has been at Robert F. Kennedy Jr.’s side reviewing candidates for top jobs at the Department of Health and Human Services.

Renewing FDA registration for a food manufacturer? This is a very specific subject, but I figured I might as well try, someone here must have knowledge on this subject. A friend has a food manufacturing plant based outside of the US (they sell via e-commerce B2C as well as large orders), they currently have (as required) a Food Facility Registration with the FDA. Their expiration is December 31s…

FDA Tries Last-Ditch Move to Slash Nicotine Levels in Cigarettes The agency is asking the White House, in the final days of the Biden era, to move ahead with plans to drastically reduce the addictive substance in traditional tobacco cigarettes.

Robert F. Kennedy Jr.’s FDA Wish List: Raw Milk, Stem Cells, Heavy Metals Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight on many fronts.

The FDA Is Finally Pulling a Useless Cold Medicine From the Market Scientists have known for years phenylephrine is ineffective.

FDA Names a New Chief of Medical Devices Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.

FDA Panel Rejects Use of MDMA for Treatment of PTSD An independent group of experts expressed concerns that the data from clinical trials did not outweigh risks for treatment of post-traumatic stress disorder.

FDA Reviews MDMA Therapy for PTSD, Citing Health Risks and Study Flaws The agency’s staff analysis suggests that approval of the illegal drug known as Ecstasy for treatment of PTSD is far from certain, with advisers meeting next week to consider the proposed therapy.

Why the FDA Keeps Recalling Eye Drops You might be tired of hearing about eye drop recalls, but the FDA has issued a new list of eye drops to stop using. This time, it includes store brand lubricant eye drops from Target, CVS, and Rite Aid. They haven’t officially been recalled, but the FDA has recommended a recall based on tests that revealed potential… Read more…

Yes, the FDA Really Did Issue a Warning About Black Licorice The FDA advisory about licorice is a few years old, but the memes about it will live on forever. “FDA issues warning about black licorice for halloween,” one headline read. And then below that, in a screenshot taken for posterity, somebody comments that the warning must have been “It tastes like shit.” Read more…

FDA Warns of Hidden Ingredients in Arthritis, Pain Products Certain products may contain active ingredients found in prescription-only drugs.

FDA Approves Pfizer’s Vaccine for Meningococcal Disease The U.S. Food and Drug Administration has approved Pfizer’s application for Penbraya, a vaccine for people 10 through 25 that will offer protection against the five main kinds of bacteria that cause meningitis and blood poisoning.

FDA Wants to Oversee Lab Tests It Says Put Patients ‘At Risk’ Genetic testing that reveals potential cancer risks or other maladies with no regulatory oversight is among the targets of the agency’s proposed review.

FDA Adds Warning of Intestinal Blockages to Ozempic Label The FDA has received more than 8,500 reports of gastrointestinal issues among people taking medications like Ozempic and Wegovy, the latter of which is approved for weight loss.

Why It Took So Long for the FDA to Tackle a Cold Medicine Pharmacists affiliated with the University of Florida have spent decades nudging the agency to pull a decongestant from over-the-counter medicines.