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Zdrowie i gospodarka · 6.05.2003

Guidance for Industry on Exposure-Response Relationships-Study Design, Data Analysis, and Regulatory Applications; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory Applications." The guidance provides recommendations for sponsors of investigational new drug applications (INDs) and applicants submitting new drug applications (NDAs) or biologics license applications (BLAs) on the use of exposure-response information in the development of drugs, including therapeutic biologics.

Source: Federal Register — Food and Drug AdministrationOpen original release →