New drug approval process

New Drug Approval Process FDA CDER (Center for Drug Evaluation and Research) Clinical Trials

Reasons for Medication Use ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Developing New Medicines Overview

Clinical Trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Discovery/Pre-Clinical Testing ,[object Object],[object Object],[object Object],[object Object]

PHASE I (file IND ) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

PHASE II ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Phase III ,[object Object],[object Object],[object Object],[object Object],[object Object]

FDA Phase IV ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

11-12 yr left on patient Medication Available to patients

Generic Medications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],What’s in a Name?~~

The Name Game ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Similar Names Error Reduction ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Summary Slide ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

New drug approval process

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New drug approval process