DTC FDA Funded Research Shows claim #1 Prescribed Has Value with Consumers Thomas Sullivan Apr 26, 2019 0 According to research funded by the FDA and published last month, participants in a study on direct-to-consumer (DTC) advertising…
False Claims Act Indivior Indicted in Alleged Multibillion-Dollar Fraud Scheme Thomas Sullivan Apr 25, 2019 0 On April 9th, the U.S. Department of Justice (DOJ) announced that a federal grand jury returned a 28-count criminal indictment…
CMS Increased Oversight and Penalties for Drug Misclassifications under the… Thomas Sullivan Apr 24, 2019 0 On April 18, 2019, President Trump signed H.R. 1839—Medicaid Services Investment and Accountability Act of 2019—into law. The new…
Uncategorized CBO Report: Prices for and Spending on Specialty Drugs in Medicare Part D… Thomas Sullivan Apr 23, 2019 0 A new Congressional Budget Office report Prices for and Spending on Specialty Drugs in Medicare Part D and Medicaid finds that net…
FDA REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is… Thomas Sullivan Apr 22, 2019 0 Recently the FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and…
Congress Bipartisanship Returns to Congress? Thomas Sullivan Apr 19, 2019 0 On April 2, 2019, the Senate Committee on Aging held a hearing to look at innovations being made in Alzheimer’s research and care…
Telemedicine Is the Future of Healthcare Online? Thomas Sullivan Apr 19, 2019 0 Telemedicine has long been discussed as a possibility of where our healthcare future lies: the ability to log into your computer…
State Policy Maine Gift Ban: Proposed Regulations Issued – $250 Limit on… Thomas Sullivan Apr 18, 2019 0 After several years, the Maine Board of Pharmacy issued its Notice of Agency Rule-making Proposal related to its gift ban law that…
FDA FDA Outlines Plans for Medical Devices with AI Thomas Sullivan Apr 17, 2019 0 We frequently hear the buzz word “AI” (artificial intelligence), usually coupled with how it’s coming for our jobs and how…
FDA FDA Defends Oversight of Generic Drugs Thomas Sullivan Apr 16, 2019 0 In response to reports questioning the FDA’s inspections and oversight of generic drugs, FDA Commissioner Scott Gottlieb and…