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Pharmaceutical Industry › Food and Drug Administration (FDA) › Interstate Commerce

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

Rivkin Radler LLP on

Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more

Knobbe Martens

A Joint Crackdown from the FTC and FDA on Medical Treatment Claims from CBD Companies

Knobbe Martens on

The Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) jointly sent warning letters on April 3, 2019 to companies that advertise and sell cannabidiol (CBD) containing products via internet...more

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Revised Memorandum of Understanding That Would Ease Restrictions on Interstate Shipment of Compounded Drugs

Akin Gump Strauss Hauer & Feld LLP on

• FDA has put out a new draft MOU for stakeholders to review and provide comments over the next 90 days. • If a state enters into the proposed MOU, pharmacies within its borders would be allowed to distribute up to 50...more

Clark Hill PLC

DELAYED: The FDA’s Intended Use Rule

Clark Hill PLC on

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

Saul Ewing LLP

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Saul Ewing LLP on

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

BakerHostetler

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

BakerHostetler on

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more

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