Federal Register notice: FDA sends to OMB an information collection extension for Reporting Associated With Animal Drug and Animal Generic Drug User F...
Two radiology professional societies say FDA is not ready to approve a pathway for authorizing autonomously functioning artificial intelligence in rad...
Three former FDA and HHS officials say there must be four safeguards in place to promote trust in any Covid-19 vaccine.
FDA releases its latest batch of Warning Letters that includes Homeocare Laboratories and Auro Pharmacies.
An FDA safety alert warns about an increased risk of a false positive result with Becton Dickinsons BD SARS-CoV-2 Reagents for the BD Max System test....
Federal Register notice: FDA seeks comments on an information collection extension for Exceptions or Alternatives To Labeling Requirements for Product...
The Justice Department says Novartis will pay $678 million to settle a whistleblower suit alleging that it operated a sham speaker program to funnel m...
The CDER Office of Prescription Drug Promotion proposes to test whether consumers are challenged by TV ads that promote more than one indication for a...