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Food and Drug Administration (FDA) Work Plans

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Baker Donelson

OIG Work Plan – October 2017 Update

Baker Donelson on

The OIG added five new items to its Work Plan with its October 2017 monthly update. This is a decrease from the nine new items added to the Work Plan with the September 2017 update. (For more information on last month's Work...more

Cooley LLP

Blog: OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement

Cooley LLP on

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The October updates include 5 new Work Plan items...more

McDermott Will & Emery

OIG Work Plan: A Roadmap to Identify Health Care Compliance Risk

Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond....more

King & Spalding

OIG Releases Mid-Year Update to its Work Plan

King & Spalding on

On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...more

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