April 18, 2024

Biosimilars Action Plan

To encourage innovation and competition in the market for biological products and facilitate the development of biosimilars and interchangeable biosimilars, FDA has developed the Biosimilars Action […]
April 18, 2024

Pharmaceutical Inspections and Compliance

FDA classifies inspections based on a company’s state of compliance as acceptable or unacceptable with respect to CGMP requirements: No action indicated (NAI) classification indicates a facility […]
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