Qalitex Laboratories Offers GMP Consulting for 21 CFR Part 111 Quality System Development

GMP Consulting Supports FDA Audits, SOPs, Testing, and GMP Readiness for Supplement Manufacturers IRVINE, CA, UNITED ...
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 Issues First-of-Its Kind Guidance on Expectations for Drug Manufacturing 483 Responses

Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 ...
FiercePharma

FDA: GMP games may land execs in jail

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 ...

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 ...
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 ...

uBriGene Congratulates Strategic Partner Grit Biotechnologies on FDA IND Clearance for Its Next-Generation GT307 TIL Therapy

GERMANTOWN, MD / ACCESS Newswire / March 16, 2026 / uBriGene Biosciences (uBriGene), a global CDMO leader, is excited to announce that its strategic partner, Grit Biotechnologies, has received FDA ...
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 ...