What staff members comprise the Office of Combination Products, and whom can I contact for specific issues?
The Office of Combination Products currently has 8 staff members: Thinh Nguyen, MS. – Director Patricia Y. Love, MD., MBA. – Associate Director Leigh Hayes, J.D. – Product Assignment Officer Janice M. Soreth, MD. – Medical Officer Kristina J. Lauritsen, Ph.D. – Scientific Reviewer Joseph Milone, Ph.D. – Scientific Reviewer John (Barr) Weiner, J.D. – Acting General Attorney Bibi Jakrali – Program Support Specialist Questions can be directed to OCP staff as follows: Assignment of combination products – to Product Assignment Officer or Director Regulatory identity of a product as a drug, device, biological product, tissue (HCT/P) or combination product – to Product Classification Officer or Director Premarketing or postmarketing issues, including requests for facilitation or guidance – to the Associate Director or the Scientific Reviewers General policy or regulatory issues – to Director or Associate Director All OCP staff can be reached either by e-mail (combination@fda.gov) or by teleph
The Office of Combination Products currently has 7 staff members: Thinh X. Nguyen – Director Patricia Y. Love, MD., MBA. – Deputy Director John (Barr) Weiner, J.D. – Associate Director for Policy and Product Classification Officer Leigh Hayes, J.D. – Product Assignment Officer Kristina J. Lauritsen, Ph.D. – Senior Scientific Reviewer Joseph Milone, Ph.D. – Senior Scientific Reviewer Bibi K. Jakrali – Management Analyst Questions can be directed to any OCP staff by e-mail (combination@fda.gov) or by telephone (301-427-1934).
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