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potential-signals-of-serious-risks/new-safety-information-identified-from-the-fda-adverse-event-reporting-system-(faers) Drug Test
  • March 5, 2025

Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)

Discover potential signals of serious risks and new safety information identified by the FDA’s Adverse Event Reporting System (FAERS). Learn…
an-update-on-sunscreen-requirements:-the-deemed-final-order-and-the-proposed-order Drug Test
  • March 5, 2025

An Update on Sunscreen Requirements: The Deemed Final Order and the Proposed Order

FDA is posting the deemed final order for over-the-counter (OTC) sunscreens and is issuing a proposed order for sunscreens. This…
pediatric-exclusivity-granted Drug Test
  • March 5, 2025

Pediatric Exclusivity Granted

Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal…
Drug Test
  • March 5, 2025

Effects of the Dietary Supplement 5α‐Hydroxy‐Laxogenin in the Orchiectomized Rat Model

The dietary supplement ingredient 5α-hydroxy-laxogenin was investigated in the castrated male rat for potential androgenic and anabolic effects. Moreover, androgen…
fda-roundup:-march-4,-2025 Drug Test
  • March 4, 2025

FDA Roundup: March 4, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
other-meeting-options-related-to-human-drugs Drug Test
  • March 4, 2025

Other Meeting Options Related to Human Drugs

Learn more about established meeting request processes for different types of meeting options related to human drugs.
personal-importation Drug Test
  • March 4, 2025

Personal Importation

Personal Importation
importing-human-drugs Drug Test
  • March 4, 2025

Importing Human Drugs

FDA importing requirements for human drug products,
navigating-controlled-correspondences-to-support-generic-drug-development-–-02/27/2025 Drug Test
  • March 4, 2025

Navigating Controlled Correspondences to Support Generic Drug Development – 02/27/2025

Navigating Controlled Correspondences to Support Generic Drug Development
untitled-letters Drug Test
  • March 4, 2025

Untitled Letters

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion’s untitled…