The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.”
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SCA Pharmaceuticals Inc. Little Rock, AR. 483 issued 10/30/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 10/30/2025
Short Title (70 char) SCA Pharmaceuticals Inc. Little Rock, AR. 483 issued 10/30/2025
FEI Number 3010683157
Firm Name SCA Pharmaceuticals Inc
Record Type 483
State AR
Establishment Type Outsourcing FaSpecial Edition Platinum 10K contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Special Edition Platinum 10K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds
Medline updates use instructions for Electronic Homecare Beds due to risk of electrical fires and entrapment.Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment
CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment durinRegulatory Pharmaceutical Fellowship Program
Explore the FDA’s Regulatory Pharmaceutical Fellowship Program, a partnership with academia and industry, offering specialized training in regulatory science, policy, and drug development. Learn how to advance your career in the pharmaceutical field through this unique fellowship opportunity.How to Participate in Emerging Technology Program (ETP)
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