FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the companys Impella ...
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.
FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.
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FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to s...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...
