In briefing documents, FDA scientists expressed concerns about whether the company, HRA Pharma, had provided sufficient data about the pill, which is already approved for prescription use.

WASHINGTON — Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday. The Food and Drug Administration said … ...

Key Takeaways: FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that ...

GREEN BAY, Wis. (WBAY) - The Food and Drug Administration is signing off on the first prescription digital treatment for depression.. It’s a smartphone app called Rejoyn for people who get a ...

FDA may soon approve the first OTC birth control pill in the U.S. And, more novel prescription-to-OTC switches could be on tap. But, the FDA’s proposed plan to facilitate more switches in new ...