Limited 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...All Drug Purchases Are
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