Update from the Office of Generic Drugs

4/15/02


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Table of Contents

Update from the Office of Generic Drugs

Topics

Office Productivity

PPT Slide

PPT Slide

PPT Slide

Office of Generic Drugs

Office of Generic Drugs

FY 2002 Appropriations

Chemistry Staffing

Chemistry Staffing

Goals

Decrease Time to Approval

Increase Science Base

Increase Science Base

Hiring and Retention

Generic Drug Quality Awareness Program

Timely Foreign Inspections

Fully Address Legal Issues

Section 505(j)(2)(A)(viii)

Section 505(j)(2)(A)(viii)

OGD Procedures

FY 2003 Appropriations

FY2003 Appropriations

PPT Slide

A Word on Electronic Submissions

Providing Regulatory Submission in Electronic Format --ANDAs

More Information

CMC Issues - Stability

CMC Issues - Stability

CMC Issues - Stability

CMC Issues - Impurities

CMC Issues - API Suppliers

Final Words...

Office of Generic Drugs

Author: Gary Buehler

Home Page: http://www.fda.gov/cder/ogd