LAURA H. CYPHERS

This Viewpoint provides recommendations for improvements to strengthen legal obligations and decrease ambiguity for the US Food and Drug Administration regarding their reliance on voluntary preapproval withdrawal pledges.
Source: JAMA Online First

This Viewpoint discusses the controversy surrounding the FDA’s efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway.
Source: JAMA Online First

This Medical News article highlights recently published research about disparities in cardiovascular health.
Source: JAMA Online First

This Viewpoint argues that reversing or restricting the use of race and ethnicity in academic admission policies could also threaten the diversity of medical schools, both directly by restricting race consciousness in medical school admission practices and indirectly by reducing the overall number of minoritized undergraduate students attending US colleges and universities who could apply to medical school.
Source: JAMA Online First

In medical research, data sharing facilitates discovery and innovation, transparency, and reproducibility, and, ultimately, trust in science. Impelled by the COVID-19 pandemic, demands for data sharing have accelerated with increasing calls for more rapid dissemination, assessment, combination, and analyses of new medical research results.
Source: JAMA Online First

This Viewpoint discusses the potential for use of nonconventional warfare threats (chemical, biological, radiological, nuclear, and explosives) in the conflict in Ukraine and how health care professionals need to recognize and respond to these threats.
Source: JAMA Online First

This JAMA Patient Page describes fentanyl and illicit fentanyl analogues, and the common signs and symptoms of fentanyl overdose, its treatment, and overdose prevention measures.
Source: JAMA Online First

In this Viewpoint from officials at NIH and FDA, the authors discuss research collaborations between federal agencies and the private sector, using new regulations for over-the-counter hearing aids as an illustration.
Source: JAMA Online First

This guideline from the International Antiviral (formerly AIDS) Society–USA updates practice recommendations for managing HIV infection, including when to change antiviral regimens; use of preexposure prophylaxis to prevent infection in at-risk persons; care of pregnant persons with HIV, people aging with HIV, and people with substance use disorder and HIV; and new challenges in people with HIV, including COVID-19 and monkeypox virus infection.
Source: JAMA Online First

This Medical News feature examines how the expiration of states’ pandemic-related licensure waivers is limiting telemedicine services.
Source: JAMA Online First