Docket Number: FDA-2019-D-0934 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes FDA’s current recommendations […]

What are Quality Metrics? For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle. Quality metrics data […]

For Immediate Release: April 05, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Image One of the U.S. Food and Drug Administration’s jobs is to carefully evaluate the scientific data on a drug to be sure that it is […]

Summary Company Announcement Date: April 05, 2024 FDA Publish Date: April 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains methanol Company […]

Docket Number: FDA-2020-D-1794 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA is announcing the availability of a guidance for industry entitled “Evaluation […]

Quick Links This page provides quick links to key guidances to support the submission of study data to FDA’s Center for Biologics Evaluation and Research (CBER), […]

[embedded content] Español 简体中文   한국어   Tagalog   Việt While we remain vigilant to protect our families and communities from the spread of COVID-19, some […]

Summary Company Announcement Date: April 04, 2024 FDA Publish Date: April 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Non-compliance with current good […]