Drug Development Links - Resource Guide for the Development of AIDS Therapies
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The following links contain information regarding drug development resources for AIDS therapies available from other government agencies.

FDA -- Center for Drug Evaluation and Research (CDER)

Contains links to drug information and regulatory guidance regarding products regulated by this Center.
FDA -- New Drug Development and Review Process
This page within the CDER website provides information regarding new drug development, IND review, and NDA review.
FDA -- Pre-IND Consultation Program
This program is designed to facilitate informal early communications between FDA and potential sponsors of new therapeutics for the treatment of AIDS. Pre-IND advice may be requested for various drug development issues.
NIEHS -- AIDS Therapeutics Toxicity Studies Program
This National Institute of Environmental Health Sciences program collaborates with government agencies and pharmaceutical companies to evaluate in rodents the reproductive/developmental toxicity, general toxicity, immunotoxicity and neurotoxicity of AIDS therapeutics.


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Last updated September 01, 2005 (ere)