US FDA Guidances Published in September 2022
The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The September 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. Quantitative Labeling of Sodium, Potassium and Phosphorous for Human Over-the-Counter and Prescription Drug Products https://www.fda.gov/media/161194/download 2. Statement of Identity and Strength – Content and...
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 Draft Guidance of Q9(R1) Quality Risk Management https://www.fda.gov/media/159218/download 2.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...