Because of the 1984 federal law, the lawsuit automatically meant that for 30 months, the F.D.A. couldn’t approve Avadel’s drug, even though, days after the suit was filed, the agency that the product was safe and effective.

Source: https://www.nytimes.com/2023/02/28/business/jazz-narcolepsy-avadel-patents.html

Judge Kacsmaryk, a Trump appointee who has written critically of the Roe v. Wade decision, had stayed his order for seven days to give the F.D.A. time to appeal.

Source: https://www.nytimes.com/2023/04/13/health/abortion-pill-ruling-appeal.html

The court also said that the F.D.A. was incorrect in saying that mifepristone was comparable in safety to ibuprofen.

Source: https://www.nytimes.com/2023/04/13/health/abortion-pill-ruling-appeal.html

The F.D.A. sent an inspector to the Olympus Medical Systems facility in Tokyo late last year.

Source: https://www.nytimes.com/2023/03/24/health/fda-duodenoscopes.html

“This strong conclusion reinforces the position of the F.D.A. and food safety agencies from more than 90 countries.”

Source: https://www.nytimes.com/2023/07/13/health/aspartame-cancer-who-sweetener.html

Two months later, the F.D.A. reversed its position, and invited Amylyx to submit its application.

Source: https://www.newyorker.com/magazine/2023/06/26/relyvrio-als-fda-approval

What we need in this country is a process for requiring manufacturers to seek F.D.A. approval where there are high rates of off-label use.

Source: https://www.nytimes.com/2023/03/05/opinion/letters/ketamine-teleheath.html