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Office of the Inspector General FDA Approval

Rivkin Radler LLP

OIG: Biopharma Company’s Provision of Free Genetic Tests Does Not Warrant Sanctions Under AKS

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With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the...more

Fox Rothschild LLP

OIG Issues Special Fraud Alert On Speaker Programs

Fox Rothschild LLP on

Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the...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

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 7 In This Month's E-News: July 2020

Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more

Epstein Becker & Green

OIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients’ Travel, Lodging, and Other Expenses

Epstein Becker & Green on

On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides...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

Skadden, Arps, Slate, Meagher & Flom LLP

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...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

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