Overhauling Compliance and GMPs

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Biologic Drugs
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Equipment
Excipients
Formulation
Packaging
Process Control/PAT
Process Development
QA/QC
Regulatory Action
Supply Chain

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Overhauling Compliance and GMPs

April 2, 2003

Jill Wechsler

Pharmaceutical Technology, Pharmaceutical Technology-04-02-2003, Volume 27, Issue 4

FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.

European Commission Approves Lumykras (Sotorasib) to Treat KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

NICE Recommends Darzalex in Combination with Velcade to Treat Multiple Myeloma

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials