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
https://www.fda.gov/media/165049/download
2. Acromegaly: Developing Drugs for Treatment
https://www.fda.gov/media/164858/download
3. Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
https://www.fda.gov/media/164690/download
4. Mpox: Development of Drugs and Biological Products
https://www.fda.gov/media/164642/download
5. Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format
https://www.fda.gov/media/72142/download
6. Format and Content of a REMS Document