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Guidance for industry ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and control

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] 2007

Guidance for industry formal dispute resolution : scientific and technical issues related to pharmac

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006] 2006

Guidance for industry PAT, a framework for innovative pharmaceutical development, manufacturing, and

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

Guidance for industry providing regulatory submissions in electronic format, drug establishment regi

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, [2009] 2009

Guidance for industry submitting type V drug master files to the Center for Biologics Evaluation and

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2001] 2001