Anti Kickback Insys Therapeutics Founder Settles with the State of New Jersey Over Role… Thomas Sullivan Jan 29, 2021 0 On January 21, 2021, Gurbir S. Grewal, Attorney General of New Jersey, announced an anticipated $5 million settlement with John…
AMA AMA to Advocate for Telemedicine Access, Even After COVID-19 Thomas Sullivan Jan 28, 2021 0 Late last year, the American Medical Association (AMA) held a virtual special meeting of its House of Delegates where a majority…
Pharmaceutical and Device PhRMA Announces Principles on Clinical Trial Diversity Thomas Sullivan Jan 27, 2021 0 Late last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced new industry-wide Principles on Conduct…
HHS Final Rule Released on the 340B Dispute Process Thomas Sullivan Jan 26, 2021 0 In mid-December 2020, the United States Department of Health and Human Services (HHS) finalized the long-awaited rule that sets…
CMS CMS Updates Guidance on Sunshine Act Reporting Thresholds for 2021 Thomas Sullivan Jan 25, 2021 0 At the end of 2020, the Centers for Medicare and Medicaid Services (CMS) issued updated guidance on the thresholds that require an…
ACCME ACCME Releases 2019 Data Report Thomas Sullivan Jan 22, 2021 0 Accredited providers within the Accreditation Council for Continuing Medical Education (ACCME) submit annual data regarding their…
False Claims Act California Genetic Testing Lab Resolves False Claims Act Allegations Thomas Sullivan Jan 21, 2021 0 In one of the first False Claims Act settlements of the year, California diagnostic laboratory Exceltox agreed to pay $357,584 to…
FDA OPDP Sends Six Warning and Untitled Letters in 2020 – Final Letter Sent to… Thomas Sullivan Jan 20, 2021 0 At the end of November 2020, the Office of Prescription Drug Promotions (OPDP) sent its sixth – and final – letter of the year to…
FDA FDA Finalizes Guidance Regarding Complex Products Meetings Thomas Sullivan Jan 19, 2021 0 Late last year, the United States Food and Drug Administration (FDA) finalized a guidance entitled, “Formal Meetings Between FDA…
BioSimilar FDA Releases Draft Question and Answers Guidance on Interchangeable… Thomas Sullivan Jan 18, 2021 0 In late 2020, the United States Food and Drug Administration (FDA) issued a draft set of four questions and answers guidance that…