Law Library

REGULATORY PROCEDURES MANUAL

CONTENTS

INTRODUCTION

CHAPTER 1 - REGULATORY ORGANIZATION

Office of Regulatory Affairs

Center for Biologics and Research

Center for Drug Evaluation and Research

Center for Devices and Radiological Health

Center for Food Safety and Applied Nutrition

Center for Veterinary Medicine

Enforcement Policy Directory

CHAPTER 2 - FDA AUTHORITY

Selected Amendments to the Federal Food, Drug, and Cosmetic Act

Other Laws

CHAPTER 3 - OTHER REGULATORY AGENCIES

Commissioning State and Local Official

Work Sharing Agreements

CHAPTER 4 - ADVISORY ACTIONS/

Warning Letters

Untitled Letters 95

CHAPTER 5 - ADMINISTRATIVE ACTIONS

Citations

Detentions

Administrative Detentions of Devices

License Revocation and Suspension

Section 305 Meeting 148

CHAPTER 6 - JUDICIAL ACTIONS

Seizure

Injunctions

Inspection Warrants

Search Warrants

Prosecutions

CHAPTER 7 - RECALL PROCEDURES

Recall Procedures

CHAPTER 8 - INFORMATION DISCLOSURE

Expert Witness

Testimony

FOIA 318

CHAPTER 9 - IMPORT OPERATIONS/ACTIONS

Import Procedures

Release Notices

Automatic Detention

Notice of Detention and Hearing

Response to Notice of Detention and Hearing

Notice of Refusal of Admission

Reconditioning

Supervisory Charges

Bond Actions

Import Information Directives

Priority Enforcement Strategy for Problem Importers

CHAPTER 10 - OTHER PROCEDURES

Prior Notice

EIR Conclusions and Decisions

ITS and Support Facilities- Classifications and Administrative Actions

Reporting and Monitoring

Ad Hoc Committee

Appeal Process 384

CHAPTER 11 - GLOSSARY AND DEFINITIONS

General Terms and Definitions

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INTRODUCTION

The purpose of this chapter is to provide an overview of the organizational structure of the offices involved in compliance related functions within the Food and Drug Administration. It is not the intent to provide a complete description as a complete description of the FDA's organizational structure and its functional statement are found in various chapters of the FDA Staff Manual Guide (SMG). This RPM chapter is divided into sections based on major organizational units, and includes a section for all centers and the Office of Regulatory Affairs. An "enforcement policy" directory, has also been provided at the end of the chapter.

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