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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of December. The selections feature topics ranging from an analysis of potential approaches for evaluating novel SARS-CoV-2 vaccine candidates after other vaccines have already been authorized; to an examination of social, cultural, and economic aspects of microbial resistance; to a study on clinical evidence supporting FDA clearance of novel therapeutics devices via the de novo pathway. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Darrow JJ, Robertson CT, Kasoff WS. Evidence Supporting the Value of Surgical Procedures: Can We Do Better? Am Surg. 2020 Dec 19:3134820979792. Epub ahead of print.
  2. Joffe S. Evaluating SARS-CoV-2 Vaccines After Emergency Use Authorization or Licensing of Initial Candidate Vaccines. JAMA. 2020 Dec 14. Epub ahead of print.
  3. Johnston JL, Dhruva SS, Ross JS, Rathi VK. Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019. JAMA Intern Med. 2020 Dec 1;180(12):1701-1703.
  4. Mehrotra P, Weber DJ, Sarpatwari A. Preventing medical-device-borne outbreaks: High-level disinfection policy for duodenoscopes. Infect Control Hosp Epidemiol. 2020 Dec 14:1-4. Epub ahead of print.
  5. Minssen T, Outterson K, Rogers Van Katwyk S, Batista PHD, Chandler CIR, Ciabuschi F, Harbarth S, Kesselheim AS, Laxminarayan R, Liddell K, Osterholm MT, Price L, Hoffman SJ. Social, cultural and economic aspects of antimicrobial resistance. Bull World Health Organ. 2020 Dec 1;98(12):823-823A.
  6. Volpp KG, Loewenstein G, Buttenheim AM. Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program. JAMA. 2020 Dec 14. [Epub ahead of print]. (PMID: 33315079).
Ameet Sarpatwari

Ameet Sarpatwari

Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

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