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Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

USA - August 13 2022 Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products…

Mike Druckman, Lowell Zeta

FDA outlines rescission of Breakthrough Therapy Designation

USA - June 28 2022 Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,”…

David M. Fox, Lynn W. Mehler

FDA issues ambitious new draft guidance to promote clinical trial diversity

USA - April 15 2022 On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in…

Stephanie Agu, Sarah Thompson Schick, Blake E. Wilson

Meta ban on health-targeting ads will soon restrict clinical trial recruiters

USA - January 12 2022 A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms - which includes restricting…

Heidi Gertner, Sally Gu, Meredith Manning, Ron Wisor

FDA RWD/RWE regulatory considerations in draft guidance highlight opportunities and challenges

USA - December 28 2021 This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence…

Sally Gu, Lynn W. Mehler, Lowell Zeta