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Zdrowie i gospodarka · 01/09/2011

FDA Releases Guidance on PET Drug Applications for New Drug Submissions

The Food and Drug Administration (FDA) has made available a new guidance document to help manufacturers of positron emission tomography (PET) drugs prepare and submit new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in compliance with federal regulations.

Source: Federal Register — Health and Human ServicesOpen original release →