FDA FDA Proposes New Right to Try Requirements Including Annual Reports from… Thomas Sullivan Aug 10, 2020 0 In a recently proposed rule, the FDA proposed Right to Try law requirements. The agency will require drug manufacturers to issue…
COVID-19 DOJ Will Allow Monoclonal Antibody Manufacturers to Share Information in… Thomas Sullivan Aug 7, 2020 0 The United States Department of Justice recently announced that it does not plan to challenge proposed efforts by a handful of…
CMS CMS to Revamp the Medicaid Drug Rebate Program: To Encompass Value Based… Thomas Sullivan Aug 6, 2020 0 Recently, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would materially modify current…
DTC Federal Trade Commission (FTC) Annual Report: Sets Their Sites on Life… Thomas Sullivan Aug 5, 2020 0 The Federal Trade Commission (“FTC”) recently released its annual report for 2019. The FTC’s annual report details the FTC’s…
FDA FDA Abandons DRD Proposal Thomas Sullivan Aug 4, 2020 0 Earlier this year, the United States Food and Drug Administration (FDA) announced it would no longer pursue a proposed regulatory…
DOJ Taro Enters into Deferred Prosecution Agreement Over Generic Drug Scheme Thomas Sullivan Aug 3, 2020 0 On July 23, 2020, the United States Department of Justice (DOJ) announced that Taro Pharmaceuticals U.S.A., Inc. (Taro) was…
CME Lung Cancer and Covid-19 in the Outpatient Setting: Accredited CME Webinars… Thomas Sullivan Jul 31, 2020 0 To assist clinicians in managing their patients with lung cancer during the current pandemic, Rockpointe, a leading continuing…
FDA Indivior Agrees to FTC Settlement Over Suboxone Claims Thomas Sullivan Jul 30, 2020 0 Recently, Indivior, Inc. agreed to pay $10 million to settle allegations by Federal Trade Commission (FTC) that it violated…
DOJ Reuters Reports PerkinElmer Under Investigation for Medicare Fraud Thomas Sullivan Jul 29, 2020 0 According to a May 18, 2020 Reuters article, the medical diagnostic firm PerkinElmer, Inc. is involved in a federal investigation…
COVID-19 ACR Issues Guidance for Pediatric Patients During COVID-19 Pandemic Thomas Sullivan Jul 28, 2020 0 Recently, the American College of Rheumatology (ACR) created two new task forces to address concerns for pediatric patients during…