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The Dynamic Environment of Laws, Regulations and Policy. Coming to Grips with uncertainty in the process. Richard M. Lewis, PhD Access BIO, LC [email protected] Or:. What are they thinking? What do they really want? What did they mean by that?. Federal Register.

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The dynamic environment of laws regulations and policy
The Dynamic Environment of Laws, Regulations and Policy.

  • Coming to Grips with uncertainty in the process



Or:

  • What are they thinking?

  • What do they really want?

  • What did they mean by that?


Federal register
Federal Register

  • Official Government Publication

  • Daily


Federal register1
Federal Register

  • Executive Orders and Proclamations

  • Rules and Regulations

  • Proposed Rules

  • Notices

    • Availability of Guidance

    • Public meetings


The laws
The Laws

  • Order of Enactment

    • Statute - Congress and Executive

    • Regulations - Executive Agency, FDA

    • Guidance - Agency, Center

    • SOP - Center


Example statute
Example: Statute

  • Food and Drug Administration Modernization Act of 1997

  • To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices and biological products, and for other purposes, Nov. 21, 1997.


Example regulation
Example Regulation

  • 21 Code of Federal Regulation

  • PART 601 -- LICENSING

  • Subpart C--Biologics Licensing

  • Sec. 601.20 Biologics licenses; issuance and conditions.

  • (a)Examination--compliance with requirements. A biologics license application shall be approved only upon examination of the product and upon a determination that the product complies with the standards established in the biologics license application and the requirements prescribed in the regulations in this chapter including but not limited to the good manufacturing practice requirements set forth in parts 210, 211, 600, 606, and 820 of this chapter.

  • (b)Availability of product. No biologics license shall be issued unless:

  • (1) The product intended for introduction into interstate commerce is available for examination, and

  • (2) Such product is available for inspection during all phases of manufacture.

  • [64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]


Example: Guidance

  • Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products February,1999.

  • Guidance for Industry: For the Submission of Chemistry, Manufacturing and Control and Establishment Description Information for Human Plasma-Derived Biological Products or Animal Plasma or Serum-Derived Products“ January 21, 1998.



Comment
Comment

  • Opportunity for comment for nearly all Regulations and Guidance

    • http://www.fda.gov/aboutfda/contactfda/commentonregulations/default.htm

  • Time

  • Form


  • What s your product
    What’s your product?

    • Where is it regulated?

    • Center and Office differences in policy.

      • Toxicology

      • Differences in GMP

        • drugs v biologics v devices


    Public meetings
    Public Meetings

    • Advisory Committees

    • Joint Industry

    • Joint Scientific

    • Part 15


    Advisory committees http www fda gov advisorycommittees
    Advisory Committeeshttp://www.fda.gov/AdvisoryCommittees

    • There are 50 different FDA advisory committees

      • Center specific

        • Office/Product specific

      • Open to the public

      • Transcripts Available from FDA (time lag)

        • Video available commercially.


    Public meetings1
    Public Meetings

    • Part 15 (21 CFR, Part 15)

    • 15.1. The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public hearing on any matter pending before the Food and Drug Administration.

    • The FDA has representatives who can ask clarifying questions.


    Organizations
    Organizations

    • BIO

    • DIA

    • Pharma

    • RAPS

    • FDLI

    • AdvaMed

    • MDMA

    • SOT

    • ASCO


    Organizations1
    Organizations

    • Annual meetings

    • Joint Workshops

      • FDA-BIO


    Meetings hosted with industry or scientific community
    Meetings hosted with Industry or Scientific Community

    • Usually on a specific issue

      • Industry Organizations

        • BIO

        • DIA

        • Pharma

      • NIH


    Services distribution lists
    Services Distribution Lists

    • BIO Smartbrief

      • Daily

    • RAPS

      • Daily

      • LinkedIn forums

    • FDA


    Specific product reviews
    Specific Product Reviews

    • Clinical

      • Pharmacology

    • CMC

    • Toxicologic

    • Statistical

    • Summary Basis for Approval


    Ema reviews
    EMA Reviews

    • EPAR: European Product Assessment Reports

      • Example: Humira, 243 pages


    Product labels
    Product Labels

    • What is there

    • What is not there


    Meetings with the fda
    Meetings with the FDA

    • Pre IND

    • IND

    • Pre Phase 3

    • Pre BLA


    Meetings
    Meetings

    • Type A: (within 30 days of request)

      • Necessary for stalled development, e.g., IND on Hold

    • Type B: (within 60 days of request)

      • PreIND, End of Phase 3/pre-phase 3, Pre-BLA/NDA

    • Type C: (within 75 days)All others.


    Enforcement
    Enforcement

    • 483s

    • warning letters

    • Untitled letters



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