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 Format of Labeling for Human Nonprescription Drug Products
https://www.fda.gov/media/161186/download
3. Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
https://www.fda.gov/media/124795/download
4. Computer Software Assurance for Production and Quality System Software
https://www.fda.gov/media/161521/download
5. ICH Q3D(R2) – Guideline for Elemental Impurities
https://www.fda.gov/media/148474/download
6. Electronic Submission Template for Medical Device 510(k) Submissions