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Inspections Department of Health and Human Services (HHS)

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

Akin Gump Strauss Hauer & Feld LLP

FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more

Arnall Golden Gregory LLP

Houston, We Have A Problem: FDA Confirms That It Will Only Conduct Mission-Critical Inspections and Prioritized Domestic...

It has been almost seven months since the Secretary of the Department of Health and Human Services (HHS) declared a public health emergency on January 31, 2020 due to the Coronavirus Disease 2019 (COVID-19).  The Food and...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....more

Bass, Berry & Sims PLC

HHS OIG Releases Five Work Plan Updates Related to COVID-19

Bass, Berry & Sims PLC on

On March 23, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its Work Plan in response to the COVID-19 pandemic. The OIG Work Plan sets forth planned or ongoing agency evaluations,...more

Arnall Golden Gregory LLP

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

Baker Donelson

OSHA Concentrates its Health Care Facility Inspections on Key Areas, but Specific Requirements Remain Elusive

Baker Donelson on

On June 25, the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) issued a press release outlining its focus areas for health care facility inspections. Musculoskeletal disorders (MSDs),...more

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