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Due Process › Food and Drug Administration (FDA) › Administrative Procedure Act

Venable LLP

FDA Announces Plan to Restrict 7-OH Opioid Products

Venable LLP on

On July 29, 2025, during a joint press conference, the U.S. Food and Drug Administration (FDA or the Agency) recommended to the Drug Enforcement Administration (DEA) to classify 7-hydroxymitragynine (7-OH) as a Schedule I...more

Akin Gump Strauss Hauer & Feld LLP

Happy Birthday Two You, IRA: Drug Pricing Dynamics to Watch as Maximum Fair Price Announcements Loom

Akin Gump Strauss Hauer & Feld LLP on

This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...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

Arnall Golden Gregory LLP

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

Arnall Golden Gregory LLP on

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

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