Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against ...
The market opportunity lies in providing specialized GMP auditing courses to pharmaceutical professionals, enhancing their skills in compliance, evaluation, and reporting, thereby ensuring ...
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good ...
MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations (CFR), are critical in ensuring safe and ethical drug administration. Whether you are ...
Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.
WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that two of its manufacturing facilities in Wuxi –Drug Product Facility 5 ...
The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries (Jan 28th - Jan 29th, 2026)" training has been added to ResearchAndMarkets.com's offering.This Auditing for GMP ...
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