FALLS CHURCH, Va., April 11, 2019 /PRNewswire-PRWeb/ -- The Accelerated Approval Pathway for Drugs and Biologics: Final
Learn firsthand from an FDA speaker on referencing best practices for the clinical trial and the endpoint to support the accelerated approval in the product label.
Heidi C. Marchand, Pharm.D. — Assistant Commissioner, Office of Health and Constituent Affairs (OHCA), Office of External Affairs in the Office of Commissioner — will review the final guidance on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway including the limitations of usefulness and uncertain clinical benefit, verified clinical benefit and withdrawal of an accelerated approved indication.
Join our upcoming webinar where one will gain an understanding of:
Discover the impact of the new labeling guidance for drugs approved under the accelerated approval pathway. Click here for additional information about the speaker, pricing, and more.
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Webinar Details: The Accelerated Approval Pathway for Drugs and Biologics: Final Labeling Guidance **An FDAnews Webinar** Thursday, April 25, 2019, 1:30 p.m. - 3:00 p.m. EDT https://www.fdanews.com/acceleratedapprovalpathway Tuition:$287 per site
Easy Ways to Register: Online: https://www.fdanews.com/acceleratedapprovalpathway By phone: 888-838-5578 or 703-538-7600
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