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What's New: Drugs RSS Feed

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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...

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...

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...

Pediatric Review Committee (PeRC)

2 days ago

Pediatric Review Committee (PeRC)

Global Generic Drug Affairs

2 days ago

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory...