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

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

• Robert A. Yetter
• Special Assistant to the Associate Director for
  Policy

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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

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21 CFR 312.31 INFORMATION AMENDMENTS

• Report essential information including
• Toxicology
• Chemistry
• Other technical information

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21 CFR 312.33ANNUAL REPORTS

• A summary of any significant manufacturing or
  microbiological changes made during the past year

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Content and Format of Investigational New Drug
Applications (INDs) for Phase 1 Studies of Drugs,
including Well-Characterized, Therapeutic
Biotechnology-derived ProductsNovember 1995
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Preliminary Draft Guidance for IndustryCMC
Content and Format of INDs for Phases 2 and 3
Studies of Drugs, Including Specified Therapeutic
Biotechnology-Derived Products December 1997
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Workshop on CMC in the Development of Drugs
Including Biotechnology-Derived ProductsIND
Phases Leading to NDA/BLADecember 15-17, 1997
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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

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BREAKOUT SESSION REPORTS

• Rolling Submission of BLA/NDA
• Appropriateness
• Reviewable unit
• Mutual agreement
• Guidance needed

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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

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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

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HOW TO GET INFORMATION FROM CBER

• Visit CBERs home page
• www.fda.gov/cber/
• Send e-mail to
• CBER_INFO_at_A1.CBER.FDA.GOV
• For a list of documents
• DOC_LIST_at_A1.CBER.FDA.GOV
• FAX Information System
• 1-888-CBER-FAX [phone] outside of U.S.)
• Telephone
• 1-800-835-4709 (301-827-1800 outside of U.S.)