[ Price : $8.95]
Israeli researchers say FDA has a robust vaccine approval and postmarketing surveillance system that worked well over the 20 years...[ Price : $8.95]
CDER director Janet Woodcock defends the Centers use of integrated reviews from criticisms that they wont meet agency goals and ma...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of Hikma International Pharmaceuticals no-longer-marketed abbreviated new animal d...[ Price : $8.95]
FDA posts a draft guidance entitled Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological P...[ Price : $8.95]
FDA issues a guidance on its regulatory approach and policy for multiple function device products.[ Price : $8.95]
FDA warns Eosera about CGMP and unapproved new drug violations in its production of OTC otic medications.[ Price : $8.95]
FDA warns Tender about CGMP and unapproved and misbranded new drug violations in its production of several over-the-counter drug p...[ Price : $8.95]
CBER says American Medical Aesthetics and Regenerative Medicine is marketing stem cell products without a valid BLA in place.