Gary Rom

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Pharmaceutical Industry

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OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment of Travel, Food and Lodging Expenses for Indigent and Rural...

In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were...more

1/15/2021 / Advisory Opinions , Anti-Kickback Statute , Civil Monetary Penalty , Food and Drug Administration (FDA) , OIG , Pharmaceutical Industry

FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more

12/2/2020 / Biosimilars , BPCIA , Draft Guidance , Food and Drug Administration (FDA) , Labeling , Licenses , Pharmaceutical Industry , Public Comment

Pacira Pharmaceuticals Pays $3.5M to Settle Allegations of Using Grants as Kickbacks

On July 28, 2020, the Department of Justice (DOJ) announced a $3.5 million settlement to resolve allegations against Pacira Pharmaceuticals Inc. that it paid kickbacks to doctors in the form of “bogus” research grants to...more

8/6/2020 / Anti-Kickback Statute , Department of Justice (DOJ) , Kickbacks , OIG , Pharmaceutical Industry

FDA Eases Regulations On Face Masks And Respirators During COVID-19 Pandemic

On March 25, 2020, the Food and Drug Administration (FDA) issued a detail-rich guidance about its “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” with the...more

4/1/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Medical Devices , Pharmaceutical Industry

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