By Ameet Sarpatwari, Aviva Wang, Liam Bendicksen, and Aaron S. Kesselheim Every month, members of the Program On Regulation, Therapeutics, And Legislation (PORTAL) overview the peer-reviewed medical literature to establish attention-grabbing empirical research, coverage analyses, and editorials on well being legislation and coverage points related to present or...
The latest protection win in Dains v. Bayer HealthCare LLC, 2022 WL 16572021 (N.D.N.Y. Nov. 1, 2022), demonstrates why many plaintiff-side counsel are well-advised to steer away from circumstances involving PMA medical gadgets. Between federal preemption and TwIqbal, not one of...
Scientific trials have detailed research protocols and are registered on ClinicalTrials.gov. What degree of particulars are wanted for real-world knowledge (RWD) analyses that goal to estimate therapy results? In Europe, the European Medicines Company (EMA) requires...
This text was initially printed in Law360 on November 14, 2022 and is republished with permission. Firms whose enterprise fashions are primarily based solely on distant provision of companies face a lot of distinctive employment legislation challenges. These challenges could be...
The abortion debate continues in America after the Supreme Court docket resolution in Dobbs v. Jackson and the midterm elections on November 8th. Following our first put up on this collection, there have been a variety of noteworthy developments* that occurred...
By Alina Schnake-Mahl, Rebecca Finkel, and Jennifer Kolker Insurance policies like paid sick depart are key instruments to forestall one other “winter of dying” and disruption, finds our current examine of U.S. cities’ sick depart and vaccination information. Additional, common paid...
As soon as once more this week we flip to the aridities of non-public jurisdiction. Or is that maybe a bit … harsh? In spite of everything, final week private jurisdiction had a uncommon second within the public highlight because of SCOTUS...
By Sarah Gabriele Filters on social media apps similar to Instagram and TikTok are nice to take foolish footage alone and with buddies, and so they usually give us a superb snicker. Nevertheless, as Dr. Christine Stabler from Penn Medication writes,...
Right now’s case is a positive prescription drug preemption determination making a key holding on newly acquired data and hostile occasion reporting. It’s a one-off case involving the prescription drug Korlym which is used to deal with Cushing’s Illness. Pietrantoni v....
Ten years after Coloradans voted for his or her state to be one of many first to legalize leisure hashish, Colorado is once more making historical past because the second state within the nation to legalize therapeutic psychedelics for adults. Colorado...
