News & Analysis as of

Extensions Food and Drug Administration (FDA)

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

McDermott+ on

THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

Foley Hoag LLP - Medicaid and the Law

In Latest Medicaid Rule, CMS Aims to Define Line Extensions

As many of our astute readers are aware, on June 17, 2020 CMS released a long-awaited Medicaid proposed rule addressing a number of far-ranging issued involving Medicaid coverage and payment for prescription drugs, including...more

Faegre Drinker Biddle & Reath LLP

New FSMA Compliance Deadlines Impact Written Customer Assurances

In an August 23 action, the U.S. Food and Drug Administration (FDA) extended a range of compliance dates and clarified compliance obligations for provisions within four foundational rules set forth by the Food Safety...more

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