FDA Guidance for Industry: Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004)

Titel:
FDA Guidance for Industry: Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004)
Herkunft/Verlag:

Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20856, Tel. 301 827 4573, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070544.pdf

Dokumentenart:
FDA Guidance for Industry
Inhalt:
Guidance for Industry Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes

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