US FDA Guidances Published in June 2022
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 Draft Guidance of Q9(R1) Quality Risk Management https://www.fda.gov/media/159218/download 2.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....
US FDA Guidances Published in May 2022
The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The May 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. FDA Updates: 1. Benefit-Risk Considerations for Product Quality Assessments https://www.fda.gov/media/158204/download 2. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors...
US FDA Guidances Published in April 2022
US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The April month has around 11 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference. FDA Updates 1. Providing Regulatory Submission in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs https://www.fda.gov/media/128163/download 2. Considerations...
US FDA Guidances Published in March 2022
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...
US FDA Guidances Published in January 2022
US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The January month has around 04 new/revised guidance under GDUFA and ICH provisions. The links of the guidance's are provided below for quick review and reference. 1. Technical Specifications for Submitting clinical trial data sets for treatment of Noncirrhotic Non-alcoholic Steatohepatitis (NASH) https://www.fda.gov/media/151870/download 2. Revising ANDA Labeling following revision...