FDA warns South Koreas Enprani Co. about CGMP and other violations in its manufacturing of finished pharmaceuticals.
CluePoints and FDA extend their cooperative research and development agreement that is exploring a data-driven approach to selecting clinical trial si...
Federal Register notice: FDA withdraws approval of 25 NDAs from multiple applicants after they notified the agency that the drug products were no long...
Federal Register notice: FDA makes available a final guidance entitled Acceptance Review for De Novo Classification Requests.
Federal Register notice: FDA announces its adoption of the most current set of the Unified Code for Units of Measure codes.
Three drug companies respond to an FDA draft guidance on package insert labeling in the drug abuse and dependence section.
Public Citizen calls on the House to improve H.R. 3 to lower drug prices and then pass the legislation.
Forbes contributor John LaMattina defends the long time needed to complete some drug post-approval studies.