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Resources

See below for some helpful pharmaceutical links.

FDA FORMS
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ListFormsNumerically/default.htm

FDA NEWS
http://www.fdanews.com/

DMF RESOURCES
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM339118.pdf

WARNING LETTERS
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#browse

FDA – CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/default.htm

FDA – OFFICE OF GENERIC DRUGS (OGD)
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm119100.htm

GENERIC DRUG USER FEE AMENDMENTS PAGE
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm

GUIDANCES – DRUGS
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

CODE OF FEDERAL REGULATIONS – TITLE 21
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

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