20140709根据GDUFA递交ANDA的修订和ECD.pdf

Guidance for Industry ANDA Submissions — Amendments and Easily Correctable Deficiencies Under GDUFA DRAFT GUIDAN CE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Elizabeth Giaquinto 240-402-7930 or (CBER) Office of Communication, Outreach, and Development, 800-835-4709 or 240-402- 7800. 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) July 2014 Generic Drugs Guidance for Industry ANDA Submissions — Amendments and Easily Correctable Deficiencies Under GDUFA Additional copies are availablefr om: Offi ce of Communications Division of Drug Inf ormation, WO51, Room 2201 Centerf or Drug Evaluation and Research Food and Drug Administration 10903 New Hamp shire Ave., Silver Spring, MD 20993