US FDA Guidances Published in November 2022
US FDA and ICH issued a series of guidance’s to assists the sponsor and applicants in the generic drug development. The November 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: 1. Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers https://www.fda.gov/media/162793/download 2. Cross Labeling Oncology Drugs in Combination Regimens...
US FDA Guidances Published in October 2022
The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development. The October month has around 09 new/revised guidance under GDUFA and DCAP provisions. The links of the guidance’s are provided below for quick review and reference. 1. Formal Meetings Between FDA and ANDA Applicants of Complex Products https://www.fda.gov/media/107626/download 2. Review of Drug Master Files in Advance of Certain ANDA Submissions...
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...