Strategies to Prepare for Meetings with the FDA

Strategies to Prepare for

Meetings with the FDA

Kim Colangelo

Associate Director for Regulatory Affairs

Office of New Drugs, CDER, FDA

Topics for Discussion

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Who Are We?

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How Do We Interact Internally?

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Why Are Meetings Important?

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How to Get the Most Out of Your Meeting

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What¡¯s New?

Who Are We?

Shared Public Health Goal:

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¡°Promote the public health by promptly and

efficiently reviewing clinical research and

taking appropriate action on the marketing of

regulated products in a timely manner¡­also

responsible for advancing the public health

by helping to speed innovations that make

medicines and foods more effective, safer,

and more affordable¡­¡±

FDA¡¯s Mission Statement

opacom/morechoices/mission.html

Who Are We?

FDA

Food Safety and Applied Nutrition

Veterinary Medicine

Drug Evaluation and Research

Field Operations/Regulatory Affairs

Devices and Radiological Health

Toxicological Research

Biologics Evaluation and Research

Who Are We?

CDER

New

Drugs

Pharmaceutical

Sciences

Biotechnology

Products

New Drug

Quality

Assessment

Translational

Sciences

Biostatistics

Surveillance

and

Epidemiology

Clinical

Pharmacology

Compliance

Manufacturing

and Product

Quality

Scientific

Investigations

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