Zdrowie i gospodarka · 03/02/2011

FDA Releases Draft Guidance on PET Drug Applications

The Food and Drug Administration (FDA) has released a draft guidance document titled "PET Drug Applications-- Content and Format for NDAs and ANDAs" to assist manufacturers of positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. The draft guidance revises a previous version issued on March 10, 2000. The FDA is also hosting a public meeting to help applicants prepare NDAs or ANDAs for specific PET imaging products.