New England Journal of Medicine
February 16, 2017 Vol. 376 No. 7
New Vaccines against Epidemic Infectious Diseases
John-Arne Røttingen, M.D., Ph.D., Dimitrios Gouglas, M.Sc., Mark Feinberg, M.D., Ph.D., Stanley Plotkin, M.D., Krishnaswamy V. Raghavan, Ph.D., Andrew Witty, B.A., Ruxandra Draghia-Akli, M.D., Ph.D., Paul Stoffels, M.D., and Peter Piot, M.D., Ph.D.
N Engl J Med 2017; 376:610-613 February 16, 2017 DOI: 10.1056/NEJMp1613577
The newly formed international Coalition for Epidemic Preparedness Innovations aims to stimulate, finance, and coordinate the development of vaccines against epidemic infectious diseases, especially in cases in which market incentives alone are insufficient.
The Common Rule, Updated
Jerry Menikoff, M.D., J.D., Julie Kaneshiro, M.A., and Ivor Pritchard, Ph.D.
N Engl J Med 2017; 376:613-615 February 16, 2017 DOI: 10.1056/NEJMp1700736
The Common Rule — the set of federal regulations for ethical conduct of human-subjects research — has finally been updated. A long process of deliberation and discussion has resulted in a final rule that differs significantly from what was initially proposed.
FDA Regulation of Prescription Drugs
Audrey L. Gassman, M.D., Christine P. Nguyen, M.D., and Hylton V. Joffe, M.D., M.M.Sc.
N Engl J Med 2017; 376:674-682 February 16, 2017 DOI: 10.1056/NEJMra1602972
Over the past 5 years, the FDA has approved 182 new drugs. This overview explains the FDA’s drug-approval process, including its approach to benefit–risk assessment, drug labeling, risk evaluation and mitigation strategies, and postmarketing surveillance.