The House Oversight Committee puts pressure on FDA and its oversight of imported Chinese and other foreign active pharmaceutical ingredients and finis...
A Phase 2b clinical study evaluating Johnson & Johnsons investigational TAR-200 monotherapy in nonmuscle-invasive bladder cancer patients with carcino...
GlycoMimetics says its Phase 3 study of uproleselan plus chemotherapy in acute myeloid leukemia patients did not achieve a statistically significant i...
FDA posts a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment" to help applicants with designing and managi...
Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that they were no longer marketed.
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...
FDA clears a ZygoFix 510(k) for its zLOCK Lumbar Facet Fixation System an implant that adapts to the joint's anatomy during insertion to offer increas...
FDA clears a Phonak 510(k) for its Phonak Lyric hearing aid and a self-replacement option to reduce office visits.
