FDA Foreign Inspection Gap Grows as U.S. Drug Imports Surge, New Study Finds

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...
JD Supra

Homeopathic drug product makers warned to follow FDA premarket and GMP rules

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 ...
JD Supra

FDA expands mutual reliance and harmonization with trusted foreign regulators for inspectional oversight - PIC/S GMP guide aims to strengthen the resiliency of globalized drug ...

The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public ...
BioTechniques

FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs

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 ...
Nasdaq

BIO-TECHNE ANNOUNCES SUBMISSION OF FDA DRUG MASTER FILE FOR EXCELLERATE GMP IPSC EXPANSION MEDIUM SUPPORTING STEM CELL THERAPY

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 ...
FiercePharma

FDA cites two for GMP lapses

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 ...

Red Light Holland Signs Definitive Agreement with Filament Health to Expand Its Platform for Natural Psychedelic Drug Development and Microdosing Innovation

Expands Red Light's drug development platform with Filament's GMP manufacturing, Health Canada Dealer's Licence, Health Canada and FDA-authorized clinical programs, and 76 issued patents covering ...
FierceBiotech

VPCI Pioneers 'Virtual GMP Consulting' for FDA Pharmaceutical Manufacturers

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 ...