CTEP Branches and Offices
Last Updated: 05/28/25
Code of Federal Regulations
Title 21 - Food and Drugs
- Part 50: Protection of Human Subjects
- Part 56: Institutional Review Boards
- Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies)
- Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
- Part 312: Investigational New Drug Application
- Part 314: Applications for FDA Approval to Market a New Drug
- Part 600: Biological Products
About the Branch Chief
Bhanu Ramineni, M.S., M.S., became the Chief of the Regulatory Affairs Branch in October 2019. She joined the Drug Regulatory Group in the branch in 2010. She holds two Master's degrees: one in Environmental Sciences from Nagarjuna University, India, and a second one in Biochemistry and Molecular Biology with a specialization in Biotechnology from Georgetown University. Ms. Ramineni comes with significant experience in FDA Regulatory Affairs, as well as preclinical and clinical development of vaccines with a special focus in immunology.
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