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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 Draft Guidance of Q9(R1) Quality Risk Management

2. Providing Regulatory Submissions in Alternate Electronic Format

MaPP Update:

3. Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA

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