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Regulatory Oversight › Constitutional Challenges › Food and Drug Administration (FDA)

Parker Poe Adams & Bernstein LLP

Is FDA's Civil Money Penalty Authority Dead, and If So, What Does It Mean for Life Sciences Companies?

Parker Poe Adams & Bernstein LLP on

Does the recent decision in a federal district court in Texas, finding that the U.S. Food and Drug Administration’s tobacco civil money penalty authority is unconstitutional, mean the end of the federal agency bringing...more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Holland & Knight LLP

Food and Beverage Law Update: December 2018

Holland & Knight LLP on

Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more

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