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 for Dosing Based on Weight or Body Surface Area for Ready-to-use Containers-Dose Banding
https://www.fda.gov/media/160036/download
3. Evaluation of Therapeutic Equivalence
https://www.fda.gov/media/160054/download
4. Failure to respond to an ANDA Complete Response Letter within the Regulatory Timeframe
https://www.fda.gov/media/160166/download
5. Orange Book Questions and Answers
https://www.fda.gov/media/138389/download
6. Conducting Remote Regulatory Assessments and Questions and Answers: Draft