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Labeling › Biologics › Federal Food Drug and Cosmetic Act (FFDCA)

Hendershot Cowart P.C.

Novo Nordisk Urges FDA to Ban Compounded Semaglutide – What Weight-Loss Clinic Owners Need to Know

Hendershot Cowart P.C. on

Novo Nordisk, the manufacturer of Ozempic and Wegovy, has petitioned the Food and Drug Administration (FDA) to add semaglutide, the active ingredient in Wegovy and Ozempic, to the "Demonstrable Difficulties for Compounding"...more

Vicente LLP

Financing Adaptogenic Mushroom Companies: Seven Basic Regulatory Points to Understand

Vicente LLP on

Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more

Hogan Lovells

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Hogan Lovells on

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

Knobbe Martens

FDA Issues Final Rule on Use of Symbols in Labeling

Knobbe Martens on

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

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