FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computational modeling and simul...
FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to s...
Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace with changes in cont...
Animal Defenders International petitions FDA to remove all references to rabbit pyrogen testing from its regulations and permit the use of validated n...
FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, a...
FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity di...
FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the companys Impella ...
FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of t...
