17th Annual Sentinel Initiative Public Workshop
The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025 SourceLimited Population Pathway for Antibacterial and Antifungal Drugs – th
On December 13, 2016, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) was added to the Federal Food, Drug, and Cosmetic (FD&C) Act through section 3042 of the 21st Century Cures Act (section 506(h) of the FD&C Act). This...Microneedling Devices: Getting to the Point on Benefits, Risks, Safety
Image EspañolBeing pricked by tiny needles may sound like a strange way to make your skin look better, but that’s the concept behind a skin care technique called microneedling. People are using microneedling in a variety of ways from reducing scarring, to treating...Potential Risks with Certain Uses of Radiofrequency Microneedling
Date Issued: October 15, 2025The U.S. Food and Drug Administration (FDA) is making consumers, patients, and health care providers aware that serious complications have been reported with certain uses of radiofrequency (RF) microneedling devices.These devices use an...SOPP Section 8500: Compliance
SOPP 8503.2: Review of Import for Export Requests Under F D & C Act Section 801(d)(4)Removed for Revision: September 1, 20098503: Import and Export RequestsSOPP 8504: Release of Establishment Inspection Reports to the Inspected Establishments Pursuant to Field...Whole Blood & Blood Components Convalescent Plasma Whole Blood-derived
STN: 125396Proper Name: Whole Blood and blood components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived).Tradename: N/AManufacturer: Stanford Blood CenterIndication:Treatment of COVID-19 in patients with immunosuppressive disease or receiving...2025 Biological License Application Supplement Noteworthy Approvals
Whole Blood and Blood Components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived)Treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment.125396/21Stanford Blood Center3373 Hillview AvenuePalo...Ben’s Original™ Issues Voluntary Recall of Select Ben’s Original Long Grain White, Whole Grain Brown, and Long Grain & Wild Ready Rice Products Due to Possible Presence of Small Stones from Farm
Summary Company Announcement Date: October 10, 2025 FDA Publish Date: October 14, 2025 Product Type: Food & Beverages Contaminants Reason for Announcement: Recall Reason Description Potential Foreign Body Contaminant – Small Stones Company Name: Ben’s Original...Click To Verify Security & Validation
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