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Clinical Review Process for New Drug Development and Application

Clinical Review Process for New Drug Development and Application. Shen Xiao, MD, Ph.D. Senior Medical Officer Division of Cardiovascular and Renal Products Center for Drug Evaluation and Research (CDER) US FDA. Disclaimer.

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Clinical Review Process for New Drug Development and Application

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  1. Clinical Review Process for New Drug Development and Application Shen Xiao, MD, Ph.D. Senior Medical Officer Division of Cardiovascular and Renal Products Center for Drug Evaluation and Research (CDER) US FDA

  2. Disclaimer • The views presented in this presentation are the opinions of the presenter and not official policy statements of the FDA.

  3. Clinical Reviewer Job Category Medical Officer • Series 0602 • Physician with active US medical license • USMLE board certified (before 2009) Clinical Analyst • Experienced Reviewers in FDA including pharmacologist, epidemiologists, other health professionals, etc.

  4. Responsibility and duty of Clinical Reviewers • New Drug Development (IND) • New Drug/Biological Products Application (NDA, BLA) • Post Marketing • Consultations • Interactions with Academia and Industry: Scientific and Regulatory activities • Medical Devices in CDRH; Biological Products in CBER

  5. New Drug/Biological Product Development (IND) • From non-clinical to first in human study including PK/PD studies • Proof of concept study-efficacy • Population selection: inclusion/exclusion criteria • Safety and efficacy determination: endpoint, drug dose-selection, safety monitoring, biomarkers, etc. • Pivotal study: special protocol assessment

  6. New Drug/Biological Product Application (NDA, BLA) • Document submission • Safety review • Efficacy review • Inspection • labeling

  7. Agency surveillances Applicant annual report Additional applicant supplements Post marketing information from other sources: published literature, patient petition, professional communities, Post Marketing

  8. Centers in FDA: Other Divisions in CDER, CBER, CDRH Other Agencies in HHS: NIH, CMS, CDC, AHRQ Other Government Agencies: DOJ, DOD, etc US Public: Patient petitions, Issues in hospitals International Regulatory Agencies: EMA, Health Canada, PMA, and TGA Consultations

  9. Questions?

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