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 ...
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.
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 ...
PRNewswire/ -- (TYO: 4978) today announced the launch of its US FDA compliant Good Manufacturing Practice (GMP) Master Cell Bank (MCB) ...
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 ...
Protracted correspondence between drugmakers and the FDA in sorting out the fixes to GMP violations is likely becoming a high-risk undertaking. The FDA has indicated that from here on in, it will have ...
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 ...
Having momentarily finished with Caraco in Michigan, FDA inspectors made their way south to Teva Animal Health in St. Joseph, MO, and then north to Apotex in Toronto. Inspectors found adulterated ...
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