US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.
The June month has around 03 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference.
1. Draft Guidance of Q9(R1) Quality Risk Management
https://www.fda.gov/media/159218/download
2. Providing Regulatory Submissions in Alternate Electronic Format
https://www.fda.gov/media/159388/download
MaPP Update:
3. Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA