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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).