[ Price : $8.95]
FDA says it will require a clinical endpoint study including an analysis of adverse events for ANDAs citing Warner Chilcotts Estra...[ Price : $8.95]
FDA issues a guidance on its implementation of the revised custom device exemption from the FDA Safety and Innovation Act.[ Price : $8.95]
Amgen files a BLA for blinatumomab, seeking approval for the investigational bispecific T cell engager (BiTE) antibody construct f...[ Price : $8.95]
FDA approves a W. L. Gore & Associates PMA for its Viabahn Endoprosthesis for interventional treatment of in-stent restenosis in t...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on generic clearance for the collection of qualitative f...[ Price : $8.95]
Federal Register Notice: FDA releases a revised draft guidance document on bioequivalence recommendations to support ANDAs for est...[ Price : $8.95]
Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will meet 12/12 to discuss a Vertiflex PMA for the Super...[ Price : $8.95]
Federal Register Notice: FDA will hold a scientific workshop 10/28-29 to discuss applying regulatory science to neonatal therapeut...