FALLS CHURCH, Va., Feb. 13, 2020 /PRNewswire-PRWeb/ -- Pharmaceutical Exclusivity: Navigating the Complex and Changing Rules An FDAnews Webinar Thursday, Feb. 27, 2020, 1:30 p.m.-3:00 p.m. EST
https://www.fdanews.com/pharmaexclusivity
Change is the only constant when it comes to FDA exclusivity rules and how they affect pharmaceutical and biological products. Not knowing the latest developments could cause major delays in development, lose years of protection and cost the company millions of dollars.
Join us on Feb. 27 to get up to speed on key updates:
? Familiarize oneself with the nuances of the new standard governing the scope of 3-year clinical investigation exclusivity and how that can affect FDA approval decisions, particularly 505(b)(2) applications ? Assess recent developments regarding orphan drug exclusivity, such as when exclusivity can be revoked and how FDA allows companies to evergreen it ? Critically evaluate the impacts of the upcoming March 23, 2020 transition of several important protein products, such as insulin, from being regulated as drugs to being regulated as biologics ? Get a sense of current legislative proposals aimed at exclusivity, including 180-day generic drug exclusivity, orphan drug exclusivity and other products
Get products to market! Join us by registering today.
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: Pharmaceutical Exclusivity: Navigating the Complex and Changing Rules An FDAnews Webinar Thursday, Feb. 27, 2020, 1:30 p.m.-3:00 p.m. EST https://www.fdanews.com/pharmaexclusivity
Tuition: $287 per site
Easy Ways to Register: Online: https://www.fdanews.com/pharmaexclusivity 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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Change is the only constant when it comes to FDA exclusivity rules and how they affect pharmaceutical and biological products. Not knowing the latest developments could cause major delays in development, lose years of protection and cost the company millions of dollars.
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Join us on Feb. 27 to get up to speed on key updates:
? Familiarize oneself with the nuances of the new standard governing the scope of 3-year clinical investigation exclusivity and how that can affect FDA approval decisions, particularly 505(b)(2) applications ? Assess recent developments regarding orphan drug exclusivity, such as when exclusivity can be revoked and how FDA allows companies to evergreen it ? Critically evaluate the impacts of the upcoming March 23, 2020 transition of several important protein products, such as insulin, from being regulated as drugs to being regulated as biologics ? Get a sense of current legislative proposals aimed at exclusivity, including 180-day generic drug exclusivity, orphan drug exclusivity and other products
Get products to market! Join us by registering today.
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: Pharmaceutical Exclusivity: Navigating the Complex and Changing Rules An FDAnews Webinar Thursday, Feb. 27, 2020, 1:30 p.m.-3:00 p.m. EST https://www.fdanews.com/pharmaexclusivity
Tuition: $287 per site
Easy Ways to Register: Online: https://www.fdanews.com/pharmaexclusivity 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
