Every technology begins with an idea – how to make something better or create something brand new. The Emerging Technology Program – or ETP – at […]

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions and to ensure that the interested […]

FDA published the final report of its join pilot program with the European Medicines Agency (EMA) for the parallel assessment of sections of applications relevant to […]

A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans.    A botanical drug product consists […]

2011 Advisory to Drug Manufacturers In 2011, FDA issued an advisory to drug manufacturers regarding the potential formation of glass lamellae (glass fragments) in injectable drugs […]

For Immediate Release: January 07, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a […]

Docket Number: FDA-2007-D-0435 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]