July – September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Signals of Serious Risks (FAERS)
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
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
Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal…
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
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
Learn more about established meeting request processes for different types of meeting options related to human drugs.