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FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to s...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...
FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, a...
FDA posts a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for products regulated b...
