pharmaphorum1mon
As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever
so sites must reevaluate their quality and safety credentials and maintain a state of good manufacturing practice (GMP) readiness. Throughout the pandemic, the lack of FDA inspections has created ...
technologynetworks9d
How Biopharma Labs Can Tackle GMP Challenges
The FDA's Good Manufacturing Practice (GMP) regulations provide a framework of essential requirements for the methods, facilities and controls used in manufacturing, processing and packaging of a drug ...
FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs
FDA halts Atara's EBVALLO and ATA3219 trials over manufacturing issues. Atara eyes $60 million milestone from Pierre Fabre upon EBVALLO approval.
Healthcare Dive36m
Adragos Pharma Acquires Baccinex – A Leading Swiss Sterile Fill-Finish Expert
Adragos Pharma, a global pharmaceutical contract development and manufacturing organization (CDMO) headquartered in Munich, ...
The Hill22d
New FDA rule could require nutrition information to be on front of packaged foods
The U.S. Food and Drug Administration (FDA) announced on Tuesday a proposal to require most food products to display nutrition information on the front of the package. The front-of-package (FOP ...
Business Wire1mon
Pluristyx Announces Immediate Availability of GMP-Compliant PSXi013 iPSC Line for Advanced Therapy Development
Streamlined Regulatory Pathway: The GMP PSXi013 iPSC line will be supported by a Drug Master File (DMF) submission to the US FDA to simplify the Investigational New Drug (IND) application process ...