US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.
The January month has around 04 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference.
1. Technical Specifications for Submitting clinical trial data sets for treatment of Noncirrhotic Non-alcoholic Steatohepatitis (NASH)
2. Revising ANDA Labeling following revision of the RLD Labeling
3. Information Requests and Discipline Review Letters Under GDUFA
4. Good ANDA Submission Practices