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By Ameet Sarpatwari, Liam Bendicksen, and Aaron S. Kesselheim
Every month, members of the Program On Regulation, Therapeutics, And Regulation (PORTAL) assessment the peer-reviewed medical literature to determine attention-grabbing empirical research, coverage analyses, and editorials on well being regulation and coverage points related to present or potential future work within the Division.
Beneath are the abstracts/summaries for papers recognized from the month of August. The choices characteristic subjects starting from a assessment of the regulatory penalties of the FDA’s accelerated approval of eteplirsen, to a comparability of the protection and effectiveness of generic and brand-name fluticasone-salmeterol for COPD, to an evaluation of free speech challenges to Medicare drug worth negotiation underneath the Inflation Discount Act. A full posting of abstracts/summaries of those articles could also be discovered on our web site.
- Bendicksen L, Zuckerman DM, Avorn J, Phillips S, Kesselheim AS. The Regulatory Repercussions of Approving Muscular Dystrophy Drugs on the Foundation of Restricted Proof. Ann Intern Med. 2023 Aug 22. Epub forward of print.
- Bhat S, Ross JS, Ramachandran R. Medical Product Trade Ties to Affected person Advocacy Organizations’ Govt Management. JAMA Intern Med. 2023 Aug 21:e232842. Epub forward of print.
- Dhruva SS, Ross JS, Wilson NA. Distinctive Gadget Identifiers for Medical Gadgets at 10 Years. JAMA Intern Med. 2023 Aug 21. Epub forward of print.
- Feldman WB, Kesselheim AS, Avorn J, Russo M, Wang SV. Comparative Effectiveness and Security of Generic Versus Model-Title Fluticasone-Salmeterol to Deal with Continual Obstructive Pulmonary Illness. Ann Intern Med. 2023 Aug;176(8):1047-1056. Epub forward of print.
- Lu A, Ji RZ, Ge AY, Ross JS, Ramachandran R, Redberg RF, Dhruva SS. Monetary Conflicts of Curiosity in Public Feedback on Medicare Nationwide Protection Determinations of Medical Gadgets. JAMA. 2023 Aug 17:e2314414. Epub forward of print.
- Neumann PJ, Tunis SR. Turning CMS right into a Well being Know-how Evaluation Group. N Engl J Med. 2023 Aug 24;389(8):682-684. Epub forward of print.
- Purohit U, Sacks CA, Raissi A, Hughes E, Boctor M, Manzoor S, Hodzic-Santor B, Zhu Okay, Raudanskis A, Ross JS, Fralick M. Press Releases of Drug-Associated Randomized Trial Outcomes Previous to Publication in Excessive-Impression Journals: an Observational Examine. J Gen Intern Med. 2023 Aug 2. Epub forward of print.
- Tu SS, Kesselheim AS, Wetherbee Okay, Feldman WB. Adjustments within the Variety of Continuation Patents on Medicine Permitted by the FDA. JAMA. 2023 Aug 1;330(5):469-470.
- Tu SS, Tushnet R. Free Speech Challenges to the Inflation Discount Act. JAMA. 2023 Aug 29. Epub forward of print.
The put up Month-to-month Spherical-Up of What to Learn on Pharma Regulation and Coverage first appeared on Invoice of Well being.
The put up Month-to-month Spherical-Up of What to Learn on Pharma Regulation and Coverage appeared first on Invoice of Well being.
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