FALLS CHURCH, Va. (PRWEB) October 15, 2020
Want to get combination products to market faster? Considering premarket submissions like 510(k), De Novo or premarket approval (PMA)?
One must adhere to a wave of legal and regulatory developments from the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). One must assess and comply with the drug patent and exclusivity provisions that now apply to drug-device combination products.
Three specialists from the FDA and Life Sciences practice of King & Spalding’s Washington, D.C. office are here help you do just that. Chris Markus, Esq. is a partner, Jessica Ringel, Esq. is counsel, and Quynh Hoang is a senior regulatory consultant.
They’ll provide tips for evaluating and addressing the new drug patent and exclusivity provisions. They will guide attendees on this new, potentially unfamiliar requirement by explaining the process and identifying resources, which can help ensure one is providing the appropriate responses and information to meet the new requirements and get products on the way to approval. Their updates will include:
- Key resources for drug patent and exclusivity information, including the FDA’s Orange Book and other online CDER resources
- Key considerations in confirming the duration of patents and exclusivity, such as additive pediatric exclusivity or patent term extensions
- Timelines and milestones in the patent certification process, including certification to FDA, direct notifications to new drug applications (NDAs) and patent holders and their effect on clearance/approval timelines
- Interactions with the drug patent holder when needed, including notifications and rights of reference
- Information to include in the marketing submission to CDRH, such as Paragraph IV certification and confirmation of notifications
Knowledge is power and knowledge of the recent legal and regulatory developments impacting combination products means the power to comply and get them to market faster.
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.
Get Your Combination Products to Market Faster:
Comply with the Latest Legal and Regulatory Developments
An FDAnews Webinar
Thursday, Oct. 29, 2020, 1:30 p.m.-3:00 p.m. EDT
$287 per site
Easy Ways to Register:
By phone: 888.838.5578 or 703.538.7600
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