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Biosimilar Interchangeability: FDA Designation, Marketing Exclusivity, Guidance, and Future Trends
Biologics are regulated by the FDA and are approved under the 351(a) pathway with a Biologics License Application (BLA).
Nov 11, 2024
Paths to Approval: Understanding U.S. Regulatory Pathways for Drug Products
This article details the potential regulatory approval pathways.
Dec 24, 2021
Understanding the Process for FDA Approval and Expedited Review
This article details the FDA evaluation process and expedited review designations.
Dec 22, 2021
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