The Accelerated Approval Pathway for Drugs and Biologics - Webinar Recording/Transcript

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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.

Webinar Takeaways:

  • 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  • Withdrawing an accelerated approved indication and removing information about the withdrawn indication from the labeling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.

  • Regulatory specialists
  • Labeling specialists
  • Quality professionals
  • Strategic planners
  • Compliance officers

Heidi C. Marchand, Pharm.D., Assistant Commissioner, Office of Health and Constituent Affairs (OHCA), Office of External Affairs in the Office of Commissioner
Heidi has responsibility for stakeholder engagement with patients and patient advocates, consumer and healthcare professional groups and organizations as well as trade organizations. She has over 18 years of experience at the FDA and began her FDA career as a Review Officer in that Division of Drug Marketing and Communications (DDMAC) in FDA’s Center for Drug Evaluation and Research (CDER). From 1997-2008, she worked for three global biopharmaceutical companies, holding leadership positions in regulatory affairs, where she interacted with the US, EU and Japanese regulatory agencies. She has developed drug and biological products under accelerated approval pathways and oversaw responsibilities for ensuring labeling updates and implementation of the physician labeling rule where managed and implemented for world-wide, marketed products.