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)
Title:
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)
Origin/Publisher:
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
Document Type:
FDA Guidance for Industry
Content:
Guidance for Industry
Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes