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Troutman Pepper

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

Troutman Pepper on

After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

Quarles & Brady LLP on

In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

Foley & Lardner LLP on

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Hazardous Materials Regulations Revisions: U.S. Pipeline and Hazardous Materials Safety Administration Addresses Industry...

Mitchell, Williams, Selig, Gates & Woodyard,... on

The United States Pipeline and Hazardous Materials Safety Administration (“PHMSA”) issued a November 7th final rule amending the federal Hazardous Materials Regulations (“HMR”). See 83 Fed. Reg. 55792. The Hazardous...more

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