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 […]

Docket Number: FDA-2015-D-3517 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

On This Page This FDA/PQRI Workshop will bring together experts from industry and senior leaders from CDER’s Office of Pharmaceutical Quality (OPQ) for interactive discussions on […]

Docket Number: FDA-2015-D-3539 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]