Combination Products Regulation, Policy & Best Practices

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Drug and device makers are bringing ever more combination products to market, even as the rules grow ever more complex and nuanced.

Now there’s an FDA Combination Products Policy Council to contend with, plus a formal pre-Request for Designation (pre-RFD) process. The 21st Century Cures Act piles on still more new rules, and expands the role of the FDA Office of Combination Products.

Bottom line? More post-market surveillance ... tougher scrutiny of ads and marketing ... greater pressure on quality and regulatory affairs departments.

But it’s still a magic moment for combination products ... as long as you stay ahead of the rules.

Here’s how:

Plan now to attend FDAnews’s first-ever all-day conference on combination products featuring 17 experts from every background — drugs, devices, biologics, generics, regulatory, legal, consulting and more. You’ll be able to:

  • Adopt three successful tactics and strategies for obtaining jurisdictional determination, assuring certainty with submission requirements, and overcoming barriers to combination product approval
  • Understand postmarket safety reporting and current good manufacturing practices requirements for combination product and constituent part sponsors to better enable you to stay in compliance with agency mandates
  • Comply with the unique considerations for advertising and marketing your combination products
  • Know the three critical findings of a human factors study of a generic combination product with device delivery constituent part
  • Implement three best practices for submitting combination products directly to CDRH and understand three important implications of the Cures Act on these submissions
     

And that’s not all. Be a fly on the wall as panelists deconstruct the process of showing the FDA a generic delivers the same level of active ingredients as a reference listed drug.

You’ll come away with a deeper understanding of the new regulatory landscape and regulatory survival strategies, including safety reporting and cGMP ... up-to-date approaches to advertising and marketing ... best practices for submitting combination products directly to the CDRH ... and much more!

View the Full-Day Agenda Here

Your conference co-chairs are David M. Fox Esq. of Hogan Lovells LLP and Quynh Hoang of King & Spalding LLP. The conference takes place in King & Spalding’s Washington DC offices, a stone’s throw from FDA headquarters.

Mr. Fox and Ms. Hoang head up an all-star cast of speakers and panelists including seven lawyers and subject experts from King & Spalding LLP, Hogan Lovells LLP and Epstein Becker & Green PC ... top executives from Pfizer, AbbVie, AstraZeneca, Becton Dickinson and Lilly ... and knowledgeable consultants from Parexel, HS Design, Navigant and UserWorks.

View the Full Speaker Lineup

It’s well worth carving a day out of your busy schedule to attend this standout session in person. Networking opportunities alone justify the trip to Washington.

But here’s good news for those who aren’t able to get away: The conference will be live-streamed, at a savings of $50 per registrant.

Combination products can be a bonanza, breathing new life into your bottom line. Don’t let government regulation stymie your goals. Attend this standout conference in person or via live stream and get the tools you need ... to do the job you mean to do. Register now.

 


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