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FDA publishes a draft guidance on the electronic submission of expedited individual case safety reports from IND-exempt BA/BE stud...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Policy Regarding N-acetyl-L-cysteine.[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Rozlytrek tablet...[ Price : $8.95]
Federal Register notice: FDA permanently debars Duniel Tejeda from providing services in any capacity to a person that has an appr...[ Price : $8.95]
The Senate Appropriations Committee posts its fiscal year 2023 proposed budget bill for FDA that increases the agencys spending by...[ Price : $8.95]
An Amgen study says the FDA accelerated approval program is working well and should not be changed because there are some drug out...[ Price : $8.95]
Jones Day attorneys update FDAs commitments for a regulatory framework to address artificial intelligence as a tool for advancing ...[ Price : $8.95]
FDA clears a bioMrieux 510(k) for its Vidas Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury.