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Enforcement Actions Health Care Providers FDA Approval

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

Hendershot Cowart P.C. on

For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Bradley Arant Boult Cummings LLP

OIG Takes Aim at Speaker Programs in Special Fraud Alert

On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Jones Day

Pharmaceutical Company Agrees to $625 Million False Claims Act Settlement

Jones Day on

The civil settlement is one of the largest FCA settlements in recent years. The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to...more

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