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
2. Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-use Containers-Dose Banding
3. Evaluation of Therapeutic Equivalence
4. Failure to respond to an ANDA Complete Response Letter within the Regulatory Timeframe
5. Orange Book Questions and Answers
6. Conducting Remote Regulatory Assessments and Questions and Answers: Draft