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 ...
REPROCELL (TYO: 4978) today announced the launch of its US FDA compliant Good Manufacturing Practice (GMP) Master Cell Bank (MCB) manufacturing service for human induced pluripotent stem cells (iPSCs) ...
Our Food, Drug & Device/FDA Group breaks down the new Food and Drug Administration guidance on data integrity for current good manufacturing practices (CGMPs) and what it means for the drug industry.
MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...
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 ...
PARSIPPANY, N.J., May 10 /PRNewswire/ -- JHP Pharmaceuticals' sterile manufacturing site based in Rochester, Michigan completed a successful GMP (Good Manufacturing Practices)/Pre Approval Audit by ...
Dublin, Jan. 16, 2026 (GLOBE NEWSWIRE) -- The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries (Jan 28th - Jan 29th, 2026)" training has been added to ...
MIAMI, Feb. 16 /PRNewswire/ -- Pharmaceutical manufacturers around the world now have access to high-level, FDA support services at the touch of a button. VPCI (Vectech Pharmaceutical Consultants ...
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