US FDA Guidances Published in August 2022
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 https://www.fda.gov/media/160561/download 2. Charging for Investigational Drugs Under an Investigational New Drug Application...
US FDA Guidances Published in July 2022
The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The July 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. Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format https://www.fda.gov/media/128446/download 2. Human Prescription Drug and Biological Products – Labeling...
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 Draft Guidance of Q9(R1) Quality Risk Management https://www.fda.gov/media/159218/download 2.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...