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- Part 2: Roles and Responsibilities of the Primary Agencies that Regulate the Products of Biotechnology.
- Part 1: 2017 Update to the Coordinated Framework for the Regulation of Biotechnology
- FDA Releases Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity Between Biosimilars
- HW reports advice from FDA, CDER reviewers
- FDA released a guidance on interchangeability earlier this year, is your company ready?