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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

2. Statement of Identity and Strength – Content and Format of Labeling for Human Nonprescription Drug Products

3. Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products

4. Computer Software Assurance for Production and Quality System Software

5. ICH Q3D(R2) – Guideline for Elemental Impurities

6. Electronic Submission Template for Medical Device 510(k) Submissions

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