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.

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.

Advancing global health through regulatory science research: summary of the Global Summit on Regulatory Science Research and Innovation.

As a first step in the implementation of the Food and Drug Administration's (FDA) Pathway to Global Product Safety and Quality (Anonymous, 2011), FDA's Office of International Programs (OIP) and the National Center for Toxicological Research (NCTR) sponsored a Global Summit on Regulatory Science Research and Innovation. Through a series of presentations and panel discussions, the Global Summit participants explored how research could be used more effectively as a tool for advancing regulatory science, food safety, medical technologies, and public health. Speakers provided an overview of each of the components in the global regulatory-science research initiative, including scientific innovation and modernizing toxicology; and discussed how the integration of these components is needed to achieve the promise of regulatory science at the global level.