US FDA and ICH issued a series of guidance’s to assists the sponsor and applicants in the generic drug development.
The November month has around 11 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference.
FDA:
1. Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
https://www.fda.gov/media/162793/download
2. Cross Labeling Oncology Drugs in Combination Regimens
https://www.fda.gov/media/162806/download
3. Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
https://www.fda.gov/media/162759/download\
4. Sameness Evaluations in an ANDA — Active Ingredients
https://www.fda.gov/media/163018/download
5. Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
https://www.fda.gov/media/154866/download
6. Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act
https://www.fda.gov/media/163367/download
7. Draft Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
https://www.fda.gov/media/163454/download
8. Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
https://www.fda.gov/media/117410/download
ICH:
9. S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals: Guidance for Industry
https://www.fda.gov/media/152777/download
10. M10 Bioanalytical Method Validation and Study Sample Analysis
https://www.fda.gov/media/162903/download
11. Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin