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CDER – Biological Product Deviations

by | Mar 14, 2025 | News

To facilitate Biological Product Deviation (BPD) reporting, FDA has developed a standardized reporting form that may be submitted electronically via e-mail or in paper format by mail to CDER. Form FDA 3486 is organized into 4 main sections:Facility...

Regulatory References | Drugs

by | Mar 14, 2025 | News

Supply ChainDrug Supply ChainSearch for Pharmaceutical Quality DocumentsPharmaceutical Quality and ManufacturingMultiple Endpoints Guidance SnapshotRegulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalEthical Considerations for Clinical...

FDA Roundup: March 14, 2025

by | Mar 14, 2025 | News

For Immediate Release: March 14, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA posted information on the flu vaccine composition for the 2025-2026 U.S. flu season. The agency,...

Eye drop pose a heightened risk of harm

by | Mar 14, 2025 | News

  Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Preservatives play a crucial...