FDA OPDP Sends First Untitled Letter of 2018 Thomas Sullivan Apr 13, 2018 0 Here we are…barely finished with the first quarter of 2018, and the United States Food and Drug Administration (FDA) Office of…
Drug Prices How Can We Increase Value and Monitor / Lower Costs? Thomas Sullivan Apr 12, 2018 0 Health Affairs and the National Pharmaceutical Council held a briefing focused on efforts to increase value and monitor costs on…
Life Science Compliance Update Coming into the Modern Era – CMS Creates Interagency Task Force to… Thomas Sullivan Apr 12, 2018 0 To control rising costs under Medicare, the Affordable Care Act, and Medicare Access and CHIP Reauthorization Act of 2015…
CMS CMS Proposes Changes to Part D and Medicare Advantage Thomas Sullivan Apr 11, 2018 0 Earlier this year, CMS proposed changes to the Medicare Advantage and Part D programs through the Advanced Notice and Draft Call…
FDA FDA Plans to Review Promotional Research Thomas Sullivan Apr 11, 2018 0 According to new releases from the FDA, it plans to look at several issues related to biopharma advertising and promotion. FDA is…
Conflict of Interest Conflicts of Interest: When Should We Pay Attention Thomas Sullivan Apr 10, 2018 0 We have previously written about financial conflicts of interest and whether physicians can disseminate impartial scientific…
Life Science Compliance Update The Day After Tomorrow – The Drug Pricing Transparency Chorus Grows Louder Thomas Sullivan Apr 10, 2018 0 Drug pricing transparency, as a concept at least, is here to stay. However, the details of what that means and the new obligations…
Congress Senate Holds Hearing on 340B Drug Pricing Program Thomas Sullivan Apr 9, 2018 0 On Thursday, March 15, 2018, the United States Senate Committee on Health, Education, Labor & Pensions held a hearing…
FDA Gottlieb Discusses Opioids and Lays Out Vision – Google it’s… Thomas Sullivan Apr 6, 2018 0 On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse…
Congress House of Representatives Holds Two-Day Hearing on Opioids Thomas Sullivan Apr 5, 2018 0 Recently the Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, “Combating the Opioid Crisis:…