FDA FDA Issues Guidance on STeP Thomas Sullivan Mar 1, 2021 0 Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance for devices and combination products,…
COVID-19 COVID Vaccine Survey of over 600 Health Care Providers: Shows 62% of Health… Thomas Sullivan Feb 27, 2021 0 Rockpointe, a continuing education company in Columbia, MD, collaborated with multiple state medical societies to develop and…
FTC FTC to Examine Impact of Hospital Acquisitions of Physician Practices on… Thomas Sullivan Feb 26, 2021 0 Earlier this year, the United States Federal Trade Commission (FTC) sent orders to six health insurance companies, seeking data on…
FDA Review of 2020 FDA Enforcement Activities Thomas Sullivan Feb 25, 2021 0 Recently, the attorneys at Ropes & Gray wrote an article reviewing the United States Food and Drug Administration’s (FDA) 2020…
FDA FDA Releases Draft Guidance on IND Submissions for Individualized Antisense… Thomas Sullivan Feb 24, 2021 0 Earlier this year, the United States Food and Drug Administration (FDA) issued draft guidance surrounding investigational new drug…
FDA Industry Seeks Clarity on Interchangeability for BsUFA III Thomas Sullivan Feb 23, 2021 0 Towards the end of last year, the United States Food and Drug Administration (FDA) opened a public docket to solicit comments on…
FDA FDA Releases Final Guidance Under GDUFA II Thomas Sullivan Feb 22, 2021 0 In mid-December 2020, the United States Food and Drug Administration finalized updated guidance to generic drug manufacturers. The…
COVID-19 Online Platform Launched to Make Telemedicine More Accessible Thomas Sullivan Feb 19, 2021 0 With COVID-19 and the rise of telemedicine, the Federation of State Medical Boards (FSMB) recently launched an online platform…
COVID-19 Coalition Calls for Further Extension of Medicare Sequester Moratorium Thomas Sullivan Feb 18, 2021 0 On February 2, 2021, America’s Physician Groups (APG) joined the coalition of groups calling for the United States Congress to…
Opioids McKinsey Settles Claims Over Its Role in the Opioid Crisis Thomas Sullivan Feb 17, 2021 0 In early February 2021, McKinsey & Company agreed to pay $573 million in a multistate settlement for its role in consulting…