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    Regulatory Considerations and Best Practices for Promoting an Accelerated Approval Product

    This article discusses processes for the successful promotion of an accelerated approval product under FDA’s 1992 Accelerated Approval Program for drugs under 21 CFR Part 314 Subpart H and for biologics under 21 CFR Part 601 Subpart E. The author offers advice for working with the company’s commercial team and FDA’s Office of Prescription Drug Promotion (OPDP) reviewers and covers considerations for label updates to a multi-indicated accelerated approval product and consi...