BackgroundThe Standard Safety Tables and Figures (ST&F) are designed to reduce clinical reviewers’ time in generating safety review content and to ensure consistency in the safety review of products across Divisions. Standards alignment has been addressed by taking...

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Author affiliations: Centers for Disease Control and Prevention, Fort...

 FDA’s generic drug Science and Research Program, created under the Generic Drug User Fee Amendments (GDUFA), is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research...

The research studies conducted under the Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. FDA's Office of Generic Drugs also publishes an annual...

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Uday Chile Brassica Pharma Pvt. Ltd. 301, Soni Palace, Haridas NagarNear Hero Honda ShowroomBorivali (West) 400092India Issuing Office: Center for Drug Evaluation and Research (CDER)...