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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.

GSK Receives Positive Opinion from CHMP for Nucala

Celltrion Gains Regulatory Nod in Korea for Regdanvimab

FDA Grants Accelerated Approval for Recurrent or Metastatic Cervical Cancer Treatment to Tivdak