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Completeness Assessments for Type II API DMFs Under GDUFA

2017-10-10 16:24      点击:
Completeness
Assessments for Type II
API DMFs Under
GDUFA
Guidance for Industry
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
October 2017
Pharmaceutical Quality/CMC/Generics
Revision 1
Completeness
Assessments for Type II
API DMFs Under
GDUFA
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: ocod@fda.hhs.gov
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)
October 2017
Pharmaceutical Quality/CMC/Generics
Revision 1
附件1-Completeness Assessments for Type II API DMFs Under GDUFA.pdf
附件2-ANDA Submissions – Refuse-to-Receive Standards_ Questions and Answers.pdf
附件3-ANDA Submissions – Prior Approval Supplements Under GDUFA.pdf
附件4-ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA.pdf
附件5-ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.pdf

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