Center for Drug Evaluation and Research (U.S.)

S2(R1) genotoxicity testing an

S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use

2008

Drugs@FDA

Drugs@FDA

2004

National drug code directory

National drug code directory

2001

Guidance for industry, q & a

Guidance for industry, q & a

2000

FDA, Center for Drug Evaluatio

FDA, Center for Drug Evaluation and Research

1997

Guideline for industry

Guideline for industry

1995

Guideline for the study of dru

Guideline for the study of drugs likely to be used in the elderly

1990

Guideline for Drug Master File

Guideline for Drug Master Files

1989

Guideline for the format and c

Guideline for the format and content of the clinical and statistical sections of an application

1988

Guideline on validation of the

Guideline on validation of the Limulus Amebocyte Lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices

1987