[04/16/2021] Update: This product has been recalled by NANA Collection LLC. See the company’s press release  for more information on the recall. This product was sold by E-Factory NY via […]

[06-15-2021] Update: This product has been recalled by miracle8989. See the company’s press release for more information on the recall. This product was sold by miracle8989 via eBay. [12-17-2020] The Food […]

When are user fees due? An application fee is due when the application is submitted to FDA. FDA issues invoices for annual program fees for the […]

On August 2, 2023, the Food and Drug Administration approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated […]

Anuncio de seguridad El 3 de julio, 2013, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) advirtió que el […]

Anuncio de seguridad [6-25-2014] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA por su sigla en inglés) advirtió acerca de ciertos productos para […]

FDA is committed to ensuring user fee resources are administered, allocated, and reported in an efficient and transparent manner. Under PDUFA VI, BsUFA II, and GDUFA […]

Background The Fit-for-Purpose (FFP) Initiative provides a pathway for regulatory acceptance of dynamic tools for use in drug development programs. Due to the evolving nature of […]

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as […]