Federal Register notice: FDA corrects a notice that appeared in the 7/8/2022 Federal Register that announced an agency determination of the regulatory...
Federal Register notice: FDA announces a 2/2/2024 advisory committee meeting to discuss pulse oximeter quality.
FDA issues one final and one draft guidance related to Section 506J notifications of medical device shortages.
FDA publishes 22 new and 18 revised product-specific guidances for developing generic drugs.
FDA publishes a guidance to help in assessing the credibility of computational modeling and simulation in medical device submissions.
An Iqvia Institute report says drug shortages continue to increase in the U.S., with the number of new shortages outpacing the number resolved.
FDA commissioner Robert Califf calls on the Healthcare Distribution Alliance to give aggregate information to the agency on the distribution of Covid ...
The central Utah federal court approves two consent decrees of permanent injunction against Evig LLC and Premium Production LLC over their distributio...
