Michelle Tessier

Faegre Drinker Biddle & Reath LLP

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New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction...more

6/24/2021 / Appeals , Consumer Fraud , Food and Drug Administration (FDA) , Homeopathic Remedies , Manufacturers , Pharmaceutical Industry , Preliminary Injunctions , Prescription Drugs , Regulatory Standards , Subject Matter Jurisdiction

FDA House Legislation Would Relax Reporting of Medical Device Malfunctions

On July 12, 2017, the U.S. House of Representatives passed a bill to reauthorize four of the U.S. Food and Drug Administration’s user fees and to change various drug and device testing rules. H.R. 2430 – the FDA...more

7/18/2017 / FDA Reauthorization Act , Food and Drug Administration (FDA) , Medical Devices , User Fees

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more

7/19/2016 / Food and Drug Administration (FDA) , Generic Drugs , Hatch-Waxman , Labeling , Manufacturers , Pharmaceutical Industry

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