Stakeholders ask FDA for greater clarification on elements in its proposed framework for drug benefit-risk analysis.
The House Commerce Subcommittee on Health announces an 11/30 hearing on Implementing the 21st Century Cures Act: An Update from FDA and NIH.
Three industry representatives take different approaches to FDA efforts to restore a balance between innovation and generic drug accessibility.
FDA warns Chinas Hubei Pharmaceutical Co. about CGMP violations in its production of active pharmaceutical ingredients.
Genentech says a Pfizer biosimilar to its Herceptin will infringe 40 Genentech patents and should be barred by a federal court injunction until the pa...
FDA approves a Medtronic PMA for its Azure pacemakers with BlueSync technology.
Federal Register notice: FDA extends its comment period provided in a 7/31 Federal Register notice entitled Cardiac Troponin Assays; Public Workshop; ...
Federal Register notice: FDA seeks comments on a petition from an undisclosed applicant requesting exemption from premarket notification requirements ...