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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 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

2. Charging for Investigational Drugs Under an Investigational New Drug Application

3. Q2(R2) Validation of Analytical Procedures

4. Q14 Analytical Procedure Development

5. M12 Drug Interaction Studies

6. E11A Paediatric Extrapolation

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