FDA sent Zimmer Biomet a warning letter in connection with the agency's April inspection of the company's Warsaw North campus. The company's quality control problems first cropped up in December 2016 ...

ElectRx has been issued a warning from the FDA after the agency found it in violation of distributing unauthorized, misbranded drugs. "Drugs that have circumvented regulatory safeguards may be ...

Before the antiviral medication is fully approved, the FDA — which typically follows the recommendations of its independent advisory committee — must conduct its own review. That's expected to ...

“This letter is intended to assist industry in improving the microbiological safety of powdered infant formula,” FDA Commissioner ... surfaces and ensuring that raw ingredients used in ...