FDA’s generic drug Science and Research Program created under the Generic Drug User Fee Amendments (GDUFA) is an essential component of FDA’s mission to protect and […]

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Since launching our Overdose Prevention Framework in August, 2022, the FDA has taken some important […]

FOOD AND DRUG ADMINISTRATIONCENTER FOR DRUG EVALUATION AND RESEARCH With Therapeutic Equivalence Evaluations PREFACE TO FORTY FOURTH EDITION The publication, Approved Drug Products With Therapeutic Equivalence Evaluations […]

The research studies conducted under the Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new […]

Summary of Proceedings FDA virtually convened its 12th intergovernmental working meeting on drug compounding with state government officials on November 7 and 8, 2023. Attendees included […]

Many serious patient illnesses and deaths linked to poor quality compounded drugs have occurred since the 2012 fungal meningitis outbreak. In response, FDA has established an […]

Summary Company Announcement Date: May 21, 2024 FDA Publish Date: May 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]

Contains Nonbinding Recommendations Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file?  Assuming each […]

For Immediate Release: May 21, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]