FDA CDER OTS Product Review & Approval
Investment ID: 009-000402093
Overview
Program Title
FDA CDER OTS Product Review & Approval
Description
OTS promotes scientific collaboration and innovation in drug regulatory review across CDER by developing and applying quantitative and statistical approaches to decision making in the regulatory review process and overseeing bioequivalence inspections to ensure the availability of safe and effective generic equivalents of investigational drugs.
Type of Program
Major IT Investments
Multi-Agency Category
Not Applicable
Investment Detail
This investment aims to modernize and promote CDER's drug regulatory review process by providing tools that advance the validity of non-clinical and clinical trial design and analysis in regulatory decision making. The tools promote scientific regulatory review and compliance as well as data management and quality.
The investment will contribute innovative and reliable solutions that improve and strengthen the scientific review process. It will enable reviewers to spend less time manipulating complex data and more time applying expertise to the analysis of quality data. The investment will also support compliance capabilities.
The investment will contribute innovative and reliable solutions that improve and strengthen the scientific review process. It will enable reviewers to spend less time manipulating complex data and more time applying expertise to the analysis of quality data. The investment will also support compliance capabilities.