Expedite generic drug applications. New FDA and congressional measures incentivize generic drug competition. This webinar gets one ready.
FALLS CHURCH, VA. (PRWEB) NOVEMBER 25, 2019
The Future of Generic Drug Competition
Deconstructing FDA and Congressional Initiatives
**An FDAnews Webinar**
Monday, Dec. 9, 2019, 1:30-3:00 p.m. EST
https://www.fdanews.com/futuregenericdrug
Nearly every day one hears a new story about the rising costs of drugs.
The FDA’s Drug Competition Action Plan (DCAP) is designed to help remove barriers to generic drug development and market entry so that consumers can get access to cost-effective medicines.
Enter Chad Landmon, Esq. and Neema Kumar, Esq., who have extensive experience in pharma law. During this webinar, they will discuss the nuances of DCAP, including efforts to improve the efficiency of the generic drug development, review and approval process; maximizing scientific and regulatory clarity with respect to complex generic drugs; and closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition congress intended. They’ll cover:
- What the various pathways are to expedite approval of generic drug applications and the advantages and disadvantages of each method
- How to expeditiously obtain 180-day exclusivity
- How a sponsor can forfeit exclusivity
- How REMS standards are being used to reduce generic competition and what can be done to combat that effort
- How FDA’s citizen petition process is being used to reduce generic competition and what can be done to combat that effort
- What congressional initiatives and measures are being proposed to spur generic drug competition
When one understands the new generic drug competition initiatives, one can successfully navigate the incentives that the FDA has put in place.
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Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
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Webinar Details:
The Future of Generic Drug Competition
Deconstructing FDA and Congressional Initiatives
**An FDAnews Webinar**
Monday, Dec. 9, 2019, 1:30-3:00 p.m. EST
https://www.fdanews.com/futuregenericdrug
Tuition:
$287 per site
Easy Ways to Register:
Online: https://www.fdanews.com/futuregenericdrug
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.
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