7/29/2025 11:01:08 PM OIG Approves Free Companion Diagnostic Testing Program for Enzyme Inhibitor Drug By Nancy Halstead Nicole Aiken-Shaban Ryan Pate The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory...
5/15/2025 8:42:55 PM Trump Executive Orders seek to encourage reshoring of pharmaceutical manufacturing and research By Vicki Tankle Sarah Thompson Schick Matthew Loughran On May 5, the Trump Administration issued a pair of executive orders that could signal big changes for the drug industry and health...
9/6/2023 8:27:12 PM New Connecticut Law Targets Drug and Device Manufacturers who Employ Sales Representatives for Additional Scrutiny By Hatmaker Pawlitz Sarah Cummings Stewart Ryan Pate Esther Haya Petrikovsky +1 more... Show less Shortly after Connecticut’s 2023 legislative session kicked off, Governor Ned Lamont announced a series of policy initiatives aimed at...
4/25/2023 3:25:08 PM HHS Proposes Bridge Access Program for COVID-19 Vaccines and Treatments By Peter Terreri On April 18, 2023, the U.S. Department of Health and Human Services (“HHS”) announced its plan to maintain access to COVID-19 vaccines...
4/12/2023 1:33:50 PM Mifepristone Cases – Our Thoughts By Scot T. Hasselman Lesley Reynolds Whitney Petrie Matthew Loughran +1 more... Show less On April 7, 2023, only minutes apart, two federal district courts issued rulings on cases challenging the Food and Drug Administration’s...
2/10/2023 5:16:18 AM Health Provisions of the Consolidated Appropriations Act, 2023: Part 3 Cosmetics Regulation By Cori Goldberg Sung Park Matthew Loughran [Note, this is Part 3 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L....
6/8/2022 6:37:01 PM FTC announces inquiry into PBM practices and orders PBMs to provide information By Joseph Metro Robert Hill Edward Schwartz William Sheridan Matthew Loughran +2 more... Show less On June 7, 2022, the Federal Trade Commission (FTC) announced that it would conduct an inquiry into the competitive impact of contracting...
3/18/2022 6:58:41 PM Competing bills propose amendments to FDA’s accelerated approval program By Brittney Cafero Taber Rueter The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”)...
12/10/2020 9:43:20 PM Long-Awaited issuance of Section 340B ADR final rule By Joseph Metro James Segroves In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an...