FDA accepts for review a Pfizer NDA for etrasimod to treat some patients with ulcerative colitis.
Celltrion USA submits a BLA to FDA for a novel subcutaneous formulation of its infliximab to be used as maintenance therapy in some ulcerative colitis...
Two JAMA articles say FDA should seek to tweak its accelerated approval program to make it easier for it to pull an approval if a confirmatory study d...
Federal Register notice: FDA is releases a draft guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
Federal Register notice: FDA posts a draft guidance entitled Content of Human Factors Information in Medical Device Marketing Submissions.
Federal Register proposed rule: FDA proposes to amend its regulations on INDs to exempt certain clinical investigations of lawfully marketed foods for...
Federal Register proposed rule: FDA proposes to replace its current annual reporting requirement for INDs with a new requirement: the annual FDA devel...
Remel recalls Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe.
