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Last updated 2 days ago

Postmarketing Requirements and Commitments: Reports

2 days ago

The Food and Drug Administration Modernization Act of 1997 requires FDA to...

Untitled Letters

2 days ago

These letters are supplied by the CDER Freedom of Information Office and...

Digital Health Technologies (DHTs) for Drug Development

3 days ago

Digital Health Technologies (DHTs) for Drug Development

Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805

3 days ago

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the...

PDUFA VIII: Fiscal Years 2028 – 2032

3 days ago

Information related to FDA’s preparation for the seventh reauthorization of PDUFA.

Find Information about a Drug

3 days ago

Information on FDA-approved drugs released for sale on the market, such as...

Drug Safety Information

3 days ago

Drug Safety Information and resources for healthcare professionals

Novel Drug Approvals for 2025

3 days ago

Innovative drugs often mean new treatment options for patients and advances in...

Drug Trials Snapshots

3 days ago

Drug Trials Snapshots: breaking down the what, how and why. Drug Trials...

Drug Trials Snapshot: NUZOLVENCE

3 days ago

Drug Trials Snapshot: NUZOLVENCE

Compounding Risk Alerts

3 days ago

FDA issues compounding risk alerts to communicate information to alert health care...