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Food and Drug Administration (FDA) › Trade Secrets › Freedom of Information Act

Ropes & Gray LLP

Protecting Trade Secrets in FDA Submissions from FOIA Disclosure in the Wake of FDA Layoffs

Ropes & Gray LLP on

In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more

Patterson Belknap Webb & Tyler LLP

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

Patterson Belknap Webb & Tyler LLP on

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

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