Cover storyContinued Process Verification In Pharma: What Literature Shows
CPV theory is well understood, but literature shows execution is uneven, here's what real-world data reveals about running Stage 3 well.
Cover storyCPV theory is well understood, but literature shows execution is uneven, here's what real-world data reveals about running Stage 3 well.

FDA's DSCSA page reinforces traceability, portal, and 24-hour illegitimate product notification obligations for distributors and manufacturers.

FibroBiologics secures U.S. Patent No. 12,716,055 for fibroblast conditioned media methods targeting degenerative disc disease, raising manufacturing and GMP questions for cell therapy CMOs.

Olympia Pharmaceuticals adds a ready-to-use Gonadorelin 1 mg/mL injection to its 503B men's hormone catalog, now available across 49 states.

FDA's CDER issued a warning letter to Peptide Partners LLC for marketing seven unapproved injectable peptides, including semaglutide and tirzepatide, online.
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