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Guidance Update Draft Guidance Prescription Drugs

Goodwin

FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

Goodwin on

On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more

Smart & Biggar

Rx IP Update - July 2019

Smart & Biggar on

Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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