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FDA Guidance - Preparation of Investigational New Drug Products

CENTER FOR DRUG EVALUATION AND RESEARCH

Guidance for Industry

The FDA published Good Guidance Practices in February 1997.

This guidance was developed and issued prior to that date.

Additional copies are available from:

Office of Training and Communications

Division of Communications Management

Drug Information Branch, HFD-210

5600 Fishers Lane

Rockville, MD 20857

(Tel) 301-827-4573

(Internet) http://www.fda.gov/cder/guidance/index.htm

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION

DEPARTMENT OP HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

GUIDELINE ON THE PREPARATION OF INVESTIGATIONAL NEW DRUG PRODUCTS (HUMAN AND ANIMAL)

MARCH 1991

(REPRINTED NOVEMBER 1992)

Guideline maintained by:

Food and Drug Administration

Center for Drug Evaluation and Research

Office of Compliance

Division of Manufacturing and Product Quality (HFD-320)

5600 Fishers Lane

Rockville, MD 20857

GUIDELINE ON THE PREPARATION OF INVESTIGATIONAL NEW DRUG PRODUCTS (HUMAN AND ANIMAL)

I. PURPOSE

This guideline informs interested persons on certain practices and procedures for the preparation of investigational new drug products for human and animal use that may be useful to persons seeking to comply with certain sections of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (Title 21 of the Code of Federal Regulations, Parts 210 and 211).

II. INTRODUCTION

The notice of availability of the draft guideline (53 FR 5835) stated that this guideline would be issued under § 10.90(b) (21 CFR 10.90(b)), which provides for the use of guidelines to establish procedures or standards of general applicability that are not legal requirements but that are acceptable to the agency. The agency is now in the process of considering whether to revise § 10.90(b). Although that decision-making process is not yet complete, the agency has decided to publish this guideline. However, this final guideline is not being issued under the authority of § 10.90(b), and, although called a guideline, it does not operate to bind the FDA or any other person in any way.


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