11/13/2025 3:33:34 AM Government Reopens . . . What Now? By Matthew Loughran The U.S. House of Representatives voted 222 to 209 to pass the Senate amendment to the continuing resolution, effectively ending the...
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...
6/27/2024 3:16:58 AM Supreme Court Decision Leaves FDA Approval of Mifepristone Untouched, But For How Long? By Scot T. Hasselman Lesley Reynolds Sarah Cummings Stewart Whitney Petrie Matthew Loughran +2 more... Show less This post was co-authored by Megan E. McWaters, a Reed Smith summer associate. In a unanimous decision, the U.S. Supreme Court overturned...
6/17/2024 2:20:05 AM The end of Chevron? Webinar to follow highly anticipated Supreme Court decision By Selina Coleman David Bender As Reed Smith has previously covered, an issue before the Supreme Court that could be decided this week could bring a seismic shift in...
3/27/2024 3:22:33 AM SCOTUS Arguments on Mifepristone Cases Focus on Standing and Remedy By Scot T. Hasselman Lesley Reynolds Whitney Petrie Matthew Loughran +1 more... Show less The U.S. Supreme Court heard arguments yesterday in the two consolidated cases challenging the U.S. Food and Drug Administration (FDA)...
9/28/2023 3:13:54 AM GOP House Bill Proposes Repeal of Retail Pharmacy Dispensing of Mifepristone By Scot T. Hasselman Whitney Petrie Matthew Loughran UPDATE: Late in the evening of September 28, the House defeated H.R. 4368 by a vote of 191-237, with 27 Republicans voting against the...
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...
3/9/2023 7:20:48 PM OIG allows drug company to provide free medication during coverage determination delay By Ellen Pighini On February 28, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory...
5/20/2022 3:34:57 PM FDA issues draft guidance for use in product quality assessments By John Kendzior On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes...
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”)...
10/14/2021 1:24:04 PM FDA codifies requirements for the medical device De Novo classification process By Andrew Lu On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device...
9/15/2021 3:09:09 PM DOJ revises approach to publication and enforcement of guidance documents By Andrew Sylora On July 1, 2021, the Department of Justice (DOJ) released a memorandum signed by Attorney General Merrick Garland regarding the issuance...
8/26/2021 12:30:14 PM FDA clarifies evidence and knowledge requirements in intended use final rule By Kevin Madagan Sung Park John Kendzior On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. §...
12/1/2020 6:27:34 PM Marketers Beware: As COVID-19 cases increase, FDA, FTC increase efforts to crack down on fraudulent and deceptive marketing and sales of purported ‘Virus Cures’ By Kevin Madagan Alison Peters The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising...
9/16/2020 4:28:08 PM FDA issues draft guidance regarding principles for selecting, developing, modifying, & adapting patient-reported outcome instruments for use in medical device evaluation By John Kendzior Ryan Pate On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing,...