FDA grants Perimeter Medical Imaging AI a breakthrough device designation for its Optical Coherence Tomography Imaging System coupled with ImgAssist A...
Federal Register notice: FDA announces a 6/7-8 public workshop entitled Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Resea...
CDRH says its response to the significant Covid-19 workload has led to delays in other product reviews.
Harvard University professors say FDA could use a change in the GDUFA fee structure to increase generic drug competition.
FDA selects Intertek as an accredited testing laboratory under the agencys Accreditation Scheme for Conformity Assessment Pilot Program.
CDER issues a MAPP outlining responsibilities for the critical path innovation meeting program.
Merck says it is stopping development of MK-7110 for treating hospitalized patients with Covid-19 due to additional FDA data requests.
FDA grants priority review to a BioMarin NDA for vosoritide to treat achondroplasia.