Federal Register notice. CDER announces a 5/12 public workshop on a Roadmap for Engaging with FDAs Center for Drug Evaluation and Research (CDER).
Federal Register notice: FDA seeks comments on an information collection extension on Human Cells, Tissues, and Cellular and Tissue-Based Products (HC...
FDA clears a Qiagen 510(k) for its Ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) for use as a qualitative in vitro diagnostic test for detecting JAK2 ...
FDA grants Akari Therapeutics a fast track designation for Coversin for treating paroxysmal nocturnal hemoglobinuria in patients who have polymorphism...
Alliance for a Stronger FDA says the agency could win or lose $40 million in the current fiscal year continuing resolution depending on whether Congre...
Merit Medical begins (XXX SUBSTITUTE XXX) a Class 1 recall of its Prelude Short Sheath Introducer due to a manufacturing defect.
An Emergo Group online post says proposed FDA user fee increases in 2018 would hurt small medical device companies most.
FDA releases its FDA-483 issued following an inspection at Indias Cadila Healthcare drug manufacturing facility.