CDER’s Most Significant
Guidance Priorities for 2021
Biosimilars/Biologics, Generics/Exclusivity,
Real-World Evidence,
Drug Development and Digital Health


Wednesday, April 21, 2021 • 1:30 p.m. - 3:00 p.m. EDT

If you’ve ever wanted a crystal ball into forthcoming guidance and 2021 priorities from the FDA’s Center for Drug Evaluation and Research (CDER), this webinar was made for you. While no proprietary information will be revealed, this timely event will share the next best thing: insights into the agency’s priorities and key areas to expect changes in its regulatory approach.

Anticipate that new guidance will almost certainly reflect important takeaways gleaned from the response to the COVID-19 pandemic in the areas of drug development, real-world evidence and digital health… as will this webinar.

Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice Kellie Combs, a Partner, and Senior Associate Sarah Blankstein — will disclose the latest changes in these areas and in biosimilars/biologics and generics and exclusivity.

Ms. Combs and Ms. Blankstein will provide up-to-the-minute information you can put to use on CDER’s new draft or final guidances as well as the associated implications. And they’ll identify areas of contention or ambiguity CDER will likely address.

Webinar Takeaways:

  • Regulatory framework for biosimilars and possible changes on the horizon with planned FDA guidance addressing labeling, promotion, interchangeability and exclusivity

  • Drug exclusivity framework and possible changes on the horizon with planned FDA guidance addressing 180-day exclusivity, pediatric exclusivity and three-year exclusivity

  • Current state of real-world evidence in drug development, key open questions and planned FDA guidance addressing regulatory considerations with the use of real-world data to support FDA decision-making for drugs and biologics

  • Emerging topics related to drug development and anticipated FDA guidance addressing decentralized clinical trials, substantial evidence and breakthrough therapy designation

  • Drug-related developments in the digital health space, including open regulatory questions and planned FDA guidance addressing use of digital health technologies in clinical trial and prescription drug-use related software

If you’ve ever wanted the inside track into CDER’s priorities, this webinar is for you. Join us by registering today.

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Who Will Benefit

  • Regulatory Affairs Personnel
  • Legal Professionals
  • Compliance Professionals

 

Meet Your Presenters

Kellie Combs

Partner
Ropes & Gray’s Life Sciences Regulatory and Compliance

Kellie Combs is a Partner in Ropes & Gray’s Life Sciences Regulatory and Compliance practice, based in Washington, D.C. She is also a Co-Chair of the firm’s cross-practice Digital Health Initiative. Ms. Combs provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, as well as hospitals and academic institutions, on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also routinely advises clients on lifecycle management, regulation of clinical research and post-approval compliance.

Sarah Blankstein

Senior Associate
Ropes & Gray’s Life Sciences Regulatory and Compliance

Sarah Blankstein is a Senior Associate in Ropes & Gray’s Life Sciences Regulatory and Compliance practice, based in Boston. Sarah provides legal and strategic advice to companies on a wide array of FDA regulatory matters, with a focus on promotional and postmarket compliance matters, lifecycle management and product development. Ms. Blankstein also regularly provides regulatory counsel for transactions as well as complex internal investigations and government enforcement matters involving issues implicating the Food, Drug, and Cosmetic Act.

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