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Will a Nonprescription Birth Control Pill Be FDA’s First Approval under its Long-Awaited “ANCU” Proposed Rule?

USA - July 20 2022 Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys…

Summer 2022 Is Here - Do You Know How the FDA User Fee Legislation Is Going?

USA - June 2 2022 Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes…

FDA Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC

USA - May 13 2022 On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8…

Jane T. Haviland

Co-Owner of Clinical Trial Company Pleads Guilty to Obstruction of Justice in Connection with Falsification of Clinical Trial Data

USA - January 18 2022 On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she…

Jane T. Haviland

Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

USA - January 5 2022 It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most…

Benjamin M. Zegarelli