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Home » FDA Guidance Urges Sponsors of Antiradiation Drugs to Consult Agency
FDA Guidance Urges Sponsors of Antiradiation Drugs to Consult Agency
February 14, 2005
Sponsors intending to submit a new drug application (NDA) or biologic license application (BLA) related to agents designed to help rid the body of radiological contamination from a terrorist attack or accident should consult with FDA officials prior to making their submissions — especially if they intend to seek approval under the Animal Efficacy Rule.