[ Price : $8.95]
FDA posts a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.[ Price : $8.95]
FDA releases a final guidance entitled Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.[ Price : $8.95]
FDA grants approval for a Taiho Oncology NDA for Lytgobi (futibatinib) for treating certain adult patients with bile duct cancer.[ Price : $8.95]
FDA sends India-based drug maker Lupin a Warning Letter after inspecting its Tarapur, Maharashtra facility 3/22 to 4/4.[ Price : $8.95]
FDA expands CDERs NextGen Portal to enable certain electronic over-the-counter monograph submissions under section 505G of the Fed...[ Price : $8.95]
FDA adds important information to the emergency authorization of AstraZenecas Evusheld to inform health care providers and individ...[ Price : $8.95]
FDA posts a draft guidance entitled Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA that introduces...[ Price : $8.95]
FDA awards the Biologics & Biosimilars Collective Intelligence Consortium a $1.3 million grant to support biosimilars research and...