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HomeHealth LawMonth-to-month Spherical-Up of What to Learn on Pharma Regulation and Coverage

Month-to-month Spherical-Up of What to Learn on Pharma Regulation and Coverage

By Ameet Sarpatwari, Alexander Egilman, andAaron S. Kesselheim

Every month, members of the Program On Regulation, Therapeutics, And Regulation (PORTAL) evaluate the peer-reviewed medical literature to establish attention-grabbing empirical research, coverage analyses, and editorials on well being regulation and coverage points.

Under are the citations for papers recognized from the month of March. The choices function matters starting from an evaluation of patent challenges by generic producers on brand-name inhalers, a dialogue of the Alliance for Hippocratic Drugs v. FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. public funding within the improvement of mRNA COVID-19 vaccines. A full posting of abstracts/summaries of those articles could also be discovered on our web site.

  1. Brown BL, Kesselheim AS, Sarpatwari A. Evaluation of Danger Analysis and Mitigation Methods for Teratogenic Medication: Variation in Major and Secondary Prevention Measures. PLoS Med. 2023 Mar 6;20(3):e1004190.
  2. Daval CJR, Bendicksen L, Kesselheim AS. Eroding Judicial Deference to the FDA – Penalties for Public Well being. N Engl J Med. 2023 Mar 16;388(11):963-966. Epub forward of print.
  3. Deshmukh AD, Kesselheim AS, Rome BN. Timing of Confirmatory Trials for Medication Granted Accelerated Approval Based mostly on Surrogate Measures From 2012 to 2021. JAMA Well being Discussion board. 2023 Mar 3;4(3):e230217.
  4. Fontrier AM, Kanavos P. Do Reimbursement Suggestions by the Canadian Company for Medication and Expertise in Well being Translate into Protection Selections for Orphan Medication within the Canadian Province of Ontario? Worth Well being. 2023 Mar 6:S1098-3015(23)00062-1. Epub forward of print.
  5. Lalani HS, Nagar S, Sarpatwari A, Barenie RE, Avorn J, Rome BN, Kesselheim AS. US Public Funding in Growth of mRNA Covid-19 Vaccines: Retrospective Cohort Research. BMJ. 2023 Mar 1;380:e073747.
  6. Patel NG, Kesselheim AS, Darrow JJ. Belief and Regulation: Assuring Scientific Independence within the FDA’s Emergency Use Authorization Course of. J Well being Polit Coverage Regulation. 2023 Mar 24:10637726. Epub forward of print.
  7. Reddy S, Beall RF, Tu SS, Kesselheim AS, Feldman WB. Patent Challenges And Litigation On Inhalers For Bronchial asthma And COPD. Well being Aff (Millwood). 2023 Mar;42(3):398-406.
  8. Sarayani A, Donahoo WT, Hampp C, Brown JD, Winterstein AG. Evaluation of the Danger Analysis and Mitigation Technique (REMS) for Phentermine-Topiramate to Forestall Publicity Throughout Being pregnant. Ann Intern Med. 2023 Mar 21. Epub forward of print.
  9. Shahzad M, Naci H, Wagner AK. Affiliation Between Preapproval Confirmatory Trial Initiation and Conversion to Conventional Approval or Withdrawal within the FDA Accelerated Approval Pathway. JAMA. 2023 Mar 7;329(9):760-761.
  10. Tu SS, Nagar S, Van de Wiele VL. Broad Patent Claims Come Earlier than the Supreme Court docket in Amgen v Sanofi. JAMA. 2023 Mar 27. Epub forward of print.
  11. Zettler PJ, Adashi EY, Cohen IG. Alliance for Hippocratic Drugs v. FDA– Dobbs’s Collateral Penalties for Pharmaceutical Regulation. N Engl J Med. 2023 Mar 9;388(10):e29. Epub forward of print.

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