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BIOLOGICS UPDATE 98 SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION TO THE IND

21 CFR 312.23(a)(7) . Information sufficient to assure proper identification, quality, purity, and strength Amount of information needed will vary phase of the investigation, proposed duration of the investigationdosage formamount of information otherwise available. 21 CFR 312.31 INFORMATION

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BIOLOGICS UPDATE 98 SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION TO THE IND

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    1. BIOLOGICS UPDATE ‘98 SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION TO THE IND Robert A. Yetter Special Assistant to the Associate Director for Policy

    2. 21 CFR 312.23(a)(7) Information sufficient to assure proper identification, quality, purity, and strength Amount of information needed will vary phase of the investigation, proposed duration of the investigation dosage form amount of information otherwise available

    3. 21 CFR 312.31 INFORMATION AMENDMENTS Report essential information including Toxicology Chemistry Other technical information

    4. 21 CFR 312.33 ANNUAL REPORTS “A summary of any significant manufacturing or microbiological changes made during the past year”

    5. Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, including Well-Characterized, Therapeutic Biotechnology-derived Products November 1995

    6. Preliminary Draft Guidance for Industry CMC Content and Format of INDs for Phases 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products December 1997

    7. Workshop on CMC in the Development of Drugs Including Biotechnology-Derived Products: IND Phases Leading to NDA/BLA December 15-17, 1997

    8. BREAKOUT SESSION REPORTS CMC submissions to the IND Amendment - Changes with the potential to affect safety Annual Report - Significant changes without the potential to affect safety

    9. BREAKOUT SESSION REPORTS Rolling Submission of BLA/NDA Appropriateness Reviewable unit Mutual agreement Guidance needed

    10. BREAKOUT SESSION REPORTS Meetings CMC end of phase 2 meeting need not coincide with clinical end of phase 2 meeting Adequate briefing package Action item list

    11. CURRENT STATUS Rolling submission incorporated into Fast Track guidance under development Meetings guidance under development CMC submissions guidance under revision to incorporate reports from workshop

    12. HOW TO GET INFORMATION FROM CBER Visit CBER’s home page: “www.fda.gov/cber/” Send e-mail to: “CBER_INFO@A1.CBER.FDA.GOV” For a list of documents: “DOC_LIST@A1.CBER.FDA.GOV” FAX Information System: 1-888-CBER-FAX (301-827-3844 outside of U.S.) Telephone: 1-800-835-4709 (301-827-1800 outside of U.S.)

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