US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.
The March month has around 02 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference.
1. Pre-Launch Activities Importation Requests (PLAIR)
https://www.fda.gov/media/86243/download
2. ICH Q14: Analytical Procedure Development
https://database.ich.org/sites/default/files/ICH_Q14_Document_Step2_Guideline_2022_0324.pdf