INDUSTRY PIPELINE

Randomization & Screen Failure

Enrollment

Trial
Discontinued

Phase 1

Phase 2

Phase 3

Begin Recruitment

SIV

IRB Approval

Site Selection


Principal Investigator & Study Staff

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FDA DEVELOPMENT AND APPROVAL PROCESS

IND Application

FDA Meetings, Reporting, Amendments

NDA/BLA Submission & Review

Office of New Drugs

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insurance coverage / reimbursement

FDA post-market surveillance

Periodic REMS Evaluation
Voluntary Reporting

Sponsors

providers

Manufacturers

Consumers

Office of Surveillance
and Epidemiology

Sentinel System
Coordinating Center

LEAD OPTIMIZATION & PRE-CLINICAL RESEARCH

LEAD COMPOUNDS

Medicinal
Chemistry/
Biological
Development

Compound for
Preclinical and
Clinical Studies
GMP & GLP Studies
Sustained Product Availability
Formulation Development & Stability