Tag Archives: FDA

2 Recent Cases Impacting False Claims Act Litigation and Investigations Deserve the Attention of Health Care Providers and Private Equity Investors

The United States Attorney’s Office for the Southern District of Florida announced on Sept. 19, 2019, that it settled a qui tam False Claims Act case in which a private equity firm was a named defendant. See United States ex rel. Medrano and Lopez v. Diabetic Care Rx LLC, d/b/a Patient Care America, et al., … Continue Reading

Draft Guidances Propose Reduced FDA Oversight of General Wellness Products and Medical Device Accessories

Decisions by the U.S. Food and Drug Administration (FDA) have a tremendous impact on Israeli-based medical and pharmaceutical companies that manufacture products that are marketed and sold in the United States and around the world. On Jan. 20, 2015, the FDA issued two anticipated draft guidance documents proposing reduced FDA oversight of two types of … Continue Reading
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