Statistical Approaches to Establishing Bioequivalence (Draft)-2022/12/2

Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies (Final)-2022/11/28

Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act (Final)-2022/11/18

Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (Draft)-2022/11/10

Sameness Evaluations in an ANDA — Active Ingredients (Draft)-2022/11/8

M10 Bioanalytical Method Validation and Study Sample Analysis (Final)-2022/11/4

Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial (Final)-2022/11/4

Cross Labeling Oncology Drugs in Combination Regimens (Final)-2022/11/2

S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals (Final)-2022/11/2

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (Draft)-2022/11/1