Jill Wechsler

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

GAO calls for more oversight of institutional review boards in clinical trials.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.