Health

Analysis of the Latest Developments Webinar Aug. 13, 2020

Leave a comment


WCG CenterWatch

WCG CenterWatch


FALLS CHURCH, Va. (PRWEB)

Expanded Access:

Analysis of the Latest Developments

An FDAnews/CenterWatch Webinar

Thursday, Sept. 10, 2020, 1:30-3:00 p.m. EDT

https://www.fdanews.com/expandedaccess

Between COVID-19 and the FDA’s announcement of Project Facilitate, expanded access is getting more momentum.

This webinar will explore the expanded access terrain, provide an update on current regulatory changes and address possible policy solutions to this treatment dilemma. Lisa Dwyer, Preeya Noronha Pinto and David Farber are partners with significant expanded access expertise in the FDA/Life Sciences practice at King & Spalding, based in Washington, DC. They will explain:

  • The existing legal and regulatory landscape driving expanded access, including 21 U.S.C. 360bbb-0 (Section 561b of the Food, Drug and Cosmetic Act)            

  • Recent congressional changes and how the FDA is implementing those changes, such as the recent FDA Proposed Rule on Annual Summary Reporting Requirements under the Right to Try Act, found at 85 Fed. Reg. 44803 (July 24, 2020)

  • The FDA’s voluntary efforts to increase use of expanded access, including the new Project Facilitate

  • Arguments in favor of and opposed to Right to Try, including whether it will help or harm patient access, if anyone is using the pathway, and whether mainstream manufacturers would ever want to use the pathway.

  • Policy considerations underlying the expanded access debate, such as monitoring and tracking of expanded access outcomes and adverse events.

  • The use of expanded access data as real-world evidence, including the use of expanded access outcomes results in the NDA review process or for coverage and reimbursement purposes.

Expanded access is evolving. Successfully navigate the new landscape.

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:

Expanded Access:

Analysis of the Latest Developments

A CenterWatch/FDAnews Webinar

Thursday, Sept. 10, 2020, 1:30-3:00 p.m. EDT

https://www.fdanews.com/expandedaccess

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/expandedaccess

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

About CenterWatch:

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

Share article on social media or email:

Leave a Reply