FDA cracks down on sponsor and researchers’ failure to publish trial data

The European Medicines Agency (EMA) has taken a similar transparency stance with clinical trials. In October 2023, the EMA ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

FDA plans ultra-fast review of three psychedelic drugs following Trump directive

The Food and Drug Administration says it will offer ultra-fast review to three psychedelic drugs being studied for ...
JD Supra

FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases

As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the ...
Regulatory Affairs Professionals Society

FDA draft guidance sets impurity controls for most antibiotics

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...
The American Journal of Managed Care

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
CBS News

FDA warns consumers about 19 cookware products that could leach lead into your food. Here's the list.

The Food and Drug Administration is warning consumers about 19 types of cookware that may contain lead, increasing the risk that the toxic metal could wind up in people's food. Consumers should ...
The Cardiology Advisor

FDA Drug Approval Decisions Expected in May 2026

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics Lic ...