[ Price : $8.95]
FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computationa...[ Price : $8.95]
FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufact...[ Price : $8.95]
Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace ...[ Price : $8.95]
Animal Defenders International petitions FDA to remove all references to rabbit pyrogen testing from its regulations and permit th...[ Price : $8.95]
FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition o...[ Price : $8.95]
FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-defi...[ Price : $8.95]
FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with t...[ Price : $8.95]
FDA posts a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for ...