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Latest posts
Last updated about 2 hours ago
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)
about 7 hours ago
The Food and Drug Administration (FDA or Agency) is announcing the availability...
Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry
about 7 hours ago
Revision 2
Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
about 20 hours ago
Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1...
Clinical Outcome Assessment (COA) Qualification Program
1 day ago
The Clinical Outcome Assessment (COA) Qualification program manages the qualification process for...
FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
1 day ago
FDA revised the EUA for bamlanivimab and etesevimab, administered together, to include...
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry
1 day ago
In October 2021, FDA incorporated Q2B Validation of Analytical Procedures: Methodology (May...
Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure
1 day ago
FDA’s surrogate endpoint table provides valuable information for drug developers on endpoints...
FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
1 day ago
Oncology
BlackBerry QNX Cybersecurity Vulnerabilities May Affect Drug Manufacturing Equipment
2 days ago
To protect public health and safety, the FDA provides guidance to drug...
Division of Pediatric and Maternal Health
2 days ago
DPMH oversees quality initiatives which promote and necessitate the study of drug...
Global Generic Drug Affairs
2 days ago
FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory...