FDA Issues Guidance for Industry on ANDAs: Impurities in Drug Products

December 16, 2010

FDA Issues Guidance for Industry on ANDAs: Impurities in Drug Products

The US Food and Drug Administration (FDA) recently announced the availability of guidance for industry entitled “ANDAs: Impurities in Drug Products”.  The guidance updates the draft document issued in December of 1998. 

The final guidance is being issued to 1) update information on listing of degradation products, setting acceptance criteria, and qualifying degradation products in abbreviated new drug applications and 2) remove those sections of the 1998 draft guidance containing recommendations that are no longer needed because they are addressed in the more recent Q3B(R).

For additional information, please visit: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Related Information:

Federal Register Notice Vol.75, No. 228, November 29, 2010http://edocket.access.gpo.gov/2010/pdf/2010-29896.pdf