FDAnews Announces CDER’s Most Significant Guidance Priorities for 2021 Webinar April 21, 2021

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Want to get a handle on CDER’s guidances and 2021 priorities? Get expert insights by registering for this webinar today.

WCG FDAnews

WCG FDAnews

CDER’s Most Significant Guidance Priorities for 2021:
Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health
An FDAnews Webinar
Wednesday, April 21, 2021, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/cder2021guidance

What might one do with advance knowledge of guidance from the FDA’s Center for Drug Evaluation and Research (CDER)? While no proprietary information will be revealed, this timely webinar will share the next best thing: insights into the agency’s priorities and key areas to expect changes in its regulatory approach.

Get up-to-the-minute information one can put to use on CDER’s new guidances regarding biosimilars, drug development, real-world evidence, generics and exclusivity and digital health.

Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice — Kellie Combs, a Partner, and Senior Associate Sarah Blankstein — will discuss the latest changes. They’ll explain what can be gleaned from the forthcoming pandemic-influenced guidances impacting drug development, real-world evidence and digital health, sharing:

  • 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.

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.

Webinar Details:
CDER’s Most Significant Guidance Priorities for 2021:
Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health
An FDAnews Webinar
Wednesday, April 21, 2021, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/cder2021guidance

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/cder2021guidance
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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Michelle Butler
FDAnews
703.538.7600
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