Hacker News with Generative AI: FDA

Top vaccine official resigns from FDA, criticizes RFK Jr (apnews.com)
The top vaccine official with the Food and Drug Administration has resigned and criticized the nation’s top health official for allowing “misinformation and lies” to guide his thinking behind the safety of vaccinations.

Health, Vaccination, Politics, FDA, Misinformation

10 points by almog 2 days ago | 0 comments

Industry Voices Alarm as Peter Marks Departs FDA (genengnews.com)
The sudden but not altogether surprising departure of Peter Marks, MD, from the FDA has prompted a chorus of criticism and despair from industry leaders and trade organizations.

FDA, Biotechnology, Regulatory Affairs

33 points by gnabgib 2 days ago | 1 comments

After 5 Years, FDA Finally Inspected Indian Drug Factory Linked to U.S. Deaths (propublica.org)
The Food and Drug Administration has found problems at an Indian factory that makes generic drugs for American patients, including one medication that was manufactured there and has been linked to at least eight deaths, federal records show.

FDA, Pharmaceuticals, India, Health, Regulation

16 points by ck2 13 days ago | 3 comments

FDA issues early alert for Baxter's Spectrum infusion pump (medicaldevice-network.com)
The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ issue with certain Baxter Sigma Spectrum and Spectrum IQ infusion pumps.

FDA, Medical Devices, Healthcare, Safety

39 points by iancmceachern 25 days ago | 46 comments

In New Administration, Supplement Makers See Chance to Cash In (undark.org)
Last fall, before being named the senior U.S. health official, Robert F. Kennedy Jr. said President Donald Trump’s administration would liberate Americans from the FDA’s “aggressive suppression” of vitamins, dietary supplements, and other substances — ending the federal agency’s “war on public health,” as he put it.

Health, Politics, Supplements, FDA

5 points by rntn 28 days ago | 0 comments

FDA cancels meeting to select flu strains for next season's shots (nbcnews.com)
A Food and Drug Administration vaccine advisory committee meeting scheduled for March to select the strains to be included in next season’s flu shot has been canceled, a panel member said Wednesday.

Health, Vaccines, Flu, FDA

21 points by taylodl 33 days ago | 1 comments

FDA asks fired scientists to return, including some reviewing Musk's Neuralink (cnbc.com)

FDA, Neuralink, Elon Musk, Science, Regulation

17 points by 1vuio0pswjnm7 36 days ago | 0 comments

FDA Approves Novel Non-Opioid Treatment for Moderate to Acute Pain (fda.gov)
Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults.

FDA, Pharmaceuticals, Pain Management, Medical News, Health

8 points by impish9208 61 days ago | 1 comments

FDA approves first new type of pain medication in 25 years (cnn.com)

FDA, Medicine, Healthcare, Pain Management

4 points by FollowingTheDao 61 days ago | 1 comments

FDA Approves drug to treat pain without opioid effects (nytimes.com)
The Food and Drug Administration approved a new medication Thursday to treat pain from an injury or surgery.

FDA, Pain Management, Pharmaceuticals, Medical News

53 points by remh 61 days ago | 32 comments

Cat and Dog Food Manufacturers Required to Consider H5N1 in Food Safety Plans (fda.gov)
The U.S. Food and Drug Administration has determined that it is necessary for manufacturers of cat and dog foods who are covered by the FDA Food Safety Modernization Act Preventive Controls for Animal Food (PCAF) rule and using uncooked or unpasteurized materials derived from poultry or cattle (e.g., uncooked meat, unpasteurized milk or unpasteurized eggs) to reanalyze their food safety plans to include Highly Pathogenic Avian Influenza virus (specifically H5N1) as a known or reasonably foreseeable hazard.

Food Safety, Animal Health, Poultry, H5N1, FDA

4 points by bookofjoe 73 days ago | 0 comments

US Food and Drug Administration moves to ban red food dye (theguardian.com)
A red food dye that is ubiquitous in American drinks, snacks, candies and cereals may finally be banned by the federal government after years of concern that it has adverse health impacts, particularly upon children.

Food Safety, Health, Regulation, FDA, Food Industry

53 points by rntn 115 days ago | 32 comments

A critical history of the FDA (midwesterndoctor.com)
How the FDA habitually buries life-changing natural medicines and relentlessly props up unsafe and ineffective pharmaceuticals

FDA, Healthcare, Medicine, History, Regulation

30 points by hams-andwich 119 days ago | 77 comments

After decades, FDA moves to pull ineffective decongestant off shelves (arstechnica.com)
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant, which the agency concluded last year is not effective at relieving stuffy noses.

Health, FDA, Pharmaceuticals, Over-the-Counter Medications

299 points by coloneltcb 145 days ago | 3 comments

FDA proposes ending use of oral phenylephrine as OTC nasal decongestant (fda.gov)
Today, the U.S. Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion after an agency review of the available data determined that oral phenylephrine is not effective for this use.

FDA, Pharmaceuticals, Health, Regulations, Nasal Congestion

303 points by impish9208 145 days ago | 508 comments

FDA Permits Marketing of Digital Game to Improve Attention in ADHD Children (2020) (fda.gov)
Today, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD).

Gaming, Health, ADHD, FDA, Digital Therapeutics

41 points by luu 153 days ago | 19 comments

The science behind on-the-wrist blood pressure tracking (empirical.health)
There are many rumors that an upcoming Apple Watch will measure blood pressure; similar features exist on Samsung watches internationally and are likely to come to the US once cleared by the FDA.

Health, Wearable Technology, Apple, Samsung, FDA

156 points by brandonb 174 days ago | 105 comments

No needles required: The FDA approves an at-home flu vaccine (npr.org)
The Food and Drug Administration has approved the first flu vaccine that people can administer to themselves at home.

Health, Pharmaceuticals, Vaccines, FDA

7 points by tambourine_man 193 days ago | 0 comments

The FDA approves an at-home nasal spray flu vaccine (npr.org)
The Food and Drug Administration has approved the first flu vaccine that people can administer to themselves at home.

Health, Vaccines, Flu, FDA

6 points by geox 193 days ago | 0 comments

FDA approves nasal flu vaccine for at-home use (nytimes.com)
The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.

Health, Medicine, Vaccines, FDA, Flu

29 points by anigbrowl 193 days ago | 1 comments

Neuralink Received Breakthrough Device Designation from the FDA for Blindsight (twitter.com)

Neuralink, FDA, Medical Technology, Blindness, Neuroscience

12 points by marc__1 196 days ago | 4 comments

Apple Watch sleep apnea detection gets FDA approval (techcrunch.com)
The US Food and Drug Administration Monday published approval for sleep apnea detection on the Apple Watch Series 9, Series 10, and Watch Ultra 2.

Health, Wearables, FDA, Apple, Sleep Apnea

464 points by brandonb 197 days ago | 316 comments

FDA Authorizes First Over-the-Counter Hearing Aid Software (fda.gov)
Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.

FDA, Hearing Aids, Technology, Health, Apple

438 points by mgerdts 201 days ago | 240 comments

Apple just got FDA approval for AirPods Pro 2's hearing aid feature (9to5mac.com)
Earlier this week, Apple announced a powerful new health feature coming to AirPods Pro 2: hearing aid. But curiously, the company shared that it had not yet received FDA approval for this ‘clinical grade’ hearing aid mode. Assuming that would happen, though, the feature would arrive later this year. As of today, however, the FDA announced it has officially approved Apple’s new feature.

Health, Consumer Electronics, Apple, FDA

6 points by alwillis 201 days ago | 0 comments

Many FDA-approved AI medical devices are not trained on real patient data (medicalxpress.com)

AI, Medical Devices, FDA, Healthcare, Data

82 points by clumsysmurf 218 days ago | 61 comments

MDMA therapy didn't get FDA approval. Now what? (vox.com)

Mental Health, Medicine, FDA

8 points by ojarow 235 days ago | 0 comments

FDA is regulating patients to death (bessstillman.substack.com)

FDA, Healthcare, Regulation, Death

9 points by vinnyvichy 239 days ago | 2 comments

FDA sued for ignoring evidence that anti-depressants numb genitals permanently (dailymail.co.uk)