FALLS CHURCH, Va., April 11, 2019 /PRNewswire-PRWeb/ -- 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
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:
Interested in registering multiple sites? Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.
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
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
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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.
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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:
- Labeling indications and usage section for products approved under the Accelerated Approval pathway
- Products approvals based upon a surrogate or intermediate clinical endpoint and inclusion in the product label
- Revising the indications and usage section upon verification of clinical benefit from post-marketing studies
- Referencing post-market study requirements for continued approval of the indication
- Withdrawals of an accelerated approved indication and removals of information about the withdrawn indication from the labeling
Interested in registering multiple sites? Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.
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
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
