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US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.

The January 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. M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms

2. Acromegaly: Developing Drugs for Treatment

3. Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research

4. Mpox: Development of Drugs and Biological Products

5. Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

6. Format and Content of a REMS Document

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