US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.
The August month has around 06 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference.
1. Electronic Submission of Expedited Safety, Reports from IND-Exempt BA/BE Studies
https://www.fda.gov/media/160561/download
2. Charging for Investigational Drugs Under an Investigational New Drug Application
https://www.fda.gov/media/161079/download
3. Q2(R2) Validation of Analytical Procedures
https://www.fda.gov/media/161201/download
4. Q14 Analytical Procedure Development
https://www.fda.gov/media/161202/download
5. M12 Drug Interaction Studies
https://www.fda.gov/media/161199/download
6. E11A Paediatric Extrapolation