Product Details
If you want to get your combination products to market faster and considering premarket submissions like 510(k), De Novo or premarket approval (PMA), this presentation is for you.
As more combination products are being introduced by devicemakers, the FDA attempted to delineate pathways for the approval of combination products that often necessitate cooperation with the Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH).
Now you must adhere to a wave of legal and regulatory developments CDER and CDRH, assessing and complying 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 you on this new, potentially unfamiliar requirement by explaining the process and identifying resources, which can help ensure you’re providing the appropriate responses and information to meet the new requirements and get your products on the way to approval.
Presentation Takeaways:
- 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.
Meet Your Presenters
Chris Markus, Esq. focuses on federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in King & Spalding’s FDA and Life Sciences practice and deputy practice group leader, she represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters and business transactions.
Jessica Ringel, Esq. is counsel in the Washington, D.C., office of King & Spalding and a member of the FDA and Life Sciences practice. Over the past 12 years, she has advised pharmaceutical and medical device companies on a wide variety of matters involving FDA regulation, both pre- and postmarket.
Quynh Hoang, Esq. is a senior regulatory consultant in the FDA and Life Sciences practice of King & Spalding’s Washington, D.C. office. She specializes in the FDA’s premarket process for medical devices and combination products with a device constituent part (e.g., 513(g), 510(k), De Novo, IDE, HDE, PMA, RFD, and Reclassification Petition), as well as in the FDA’s postmarket process for adverse signals.
Geneviève Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.
Recognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.
- Regulatory Affairs Staff
- In-House Counsel
- Management
- Consultants for Device-Led Combination Products