FDA ISSUES CHECKLIST FOR ANDAs

The FDA CDER recently issued a checklist for filing ANDAs to ensure completeness and acceptability of an application.

To view the FDA issued checklist, CLICK HERE. Additionally, to prevent confusion among PET manufacturers who may be submitting an ANDA for the first time, we have simplified this checklist. To view the shortened checklist, CLICK HERE.

All of the items listed (except form 3674) are detailed in the Guidance PET Drug Applications Content and Format for NDAs and ANDAs Feb 2011: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078738.pdf

Form 356h and 3674 may also be downloaded from the FDA website: http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm

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