The Accelerated Approval Pathway for Drugs and Biologics - Webinar Recording/Transcript
The Accelerated Approval Pathway for Drugs and Biologics: Final Labeling Guidance
In January, the FDA released the final guidance on Labeling for Human Prescription Drug and Biological Products Approved under the Accelerated Approval Regulatory Pathway. It outlines FDA's recommendations for developing the indications and usage statements in the prescribing information for drugs and biologics, approved under the accelerated approval pathway.
If you’re considering using the accelerated approval pathway, get ready for the guidance’s impact on your labeling.
- Labeling indications and usage section for products approved under the Accelerated Approval pathway
- Revising indications and usage section upon verification of clinical benefit from post-marketing studies
- Approving products based upon a surrogate or intermediate clinical endpoint and inclusion in the product label
- Referencing the clinical trial and the endpoint to support accelerated approval in the indications and usage section
- Referencing post-market study requirements for continued approval of the indication
- Withdrawing an accelerated approved indication and removing information about the withdrawn indication from the labeling
Discover the impact of the new labeling guidance for drugs approved under the accelerated approval pathway. Join us by registering today.