Judicial interference with mifepristone.

In the days since Texas federal judge Matthew J. Kacsmaryk invalidated the approval by the US Food and Drug Administration (FDA) of mifepristone, a medication used to terminate pregnancy, a shock wave of concern has swept through many people, organizations, and companies that work closely with the agency. The strong opposition reflects the high stakes not only for pregnant persons and for the FDA, but also for the scientific process of drug development and public access to safe and effective medications.

Transparency practices at the FDA: A barrier to global health.

Data sharing among regulators must be "business as usual".

Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency.

Seven former commissioners of the Food and Drug Administration (FDA) from both sides of the political aisle recommend that the FDA be moved out of the Department of Health and Human Services and reconfigured as an independent federal agency. We believe that such a reengineering would promote reliance on consistent science-based regulation and ensure that the American public has access to the best that science and industry can offer.

Vital Directions for Health and Health Care: Priorities From a National Academy of Medicine Initiative.

Importance: Recent discussion has focused on questions related to the repeal and replacement of portions of the Affordable Care Act (ACA). However, issues central to the future of health and health care in the United States transcend the ACA provisions receiving the greatest attention. Initiatives directed to certain strategic and infrastructure priorities are vital to achieve better health at lower cost.

Food for love: the role of food offering in empathic emotion regulation.

The present article examines the interpersonal and intrapersonal antecedents and consequences of food offering. Food offering is one of the earliest biobehavioral regulatory interactions between parent and child. It ensures survival of the child who is fully dependent on food provision by others.

Creating a space for innovative device development.

The FDA announces a partnership with a new nonprofit organization--the Medical Device Innovation Consortium--to advance regulatory science in the medical technology arena.

Management of hyperglycemia with the administration of intravenous exenatide to patients in the cardiac intensive care unit.

Objective: To evaluate the feasibility, effectiveness, and safety of intravenous exenatide to control hyperglycemia in the cardiac intensive care unit (CICU).

Methods: A prospective, single-center, open-label, nonrandomized pilot study. Forty patients admitted to the CICU with glucose levels of 140 to 400 mg/dL received intravenous exenatide as a bolus followed by a fixed dose infusion for up to 48 hours.

Advancing the science of medicines regulation: the role of the 21st-century medicines regulator.

The history of medicines regulation is punctuated with sudden swings in focus mandated by a public injured by medicines and skeptical of regulators' abilities to protect them. As stakeholder communities and the science that undergirds medicines have both grown more sophisticated, seemingly conflicting mission equities, such as public health protection vs. promotion or population vs.