1 / 27

The Dynamic Environment of Laws, Regulations and Policy.

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

lazar
Download Presentation

The Dynamic Environment of Laws, Regulations and Policy.

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The Dynamic Environment of Laws, Regulations and Policy. • Coming to Grips with uncertainty in the process

  2. Richard M. Lewis, PhD Access BIO, LC rlewis@accessbio.com

  3. Or: • What are they thinking? • What do they really want? • What did they mean by that?

  4. Federal Register • Official Government Publication • Daily

  5. Federal Register • Executive Orders and Proclamations • Rules and Regulations • Proposed Rules • Notices • Availability of Guidance • Public meetings

  6. The Laws • Order of Enactment • Statute - Congress and Executive • Regulations - Executive Agency, FDA • Guidance - Agency, Center • SOP - Center

  7. 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.

  8. 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]

  9. 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.

  10. CBER SOPP, Sections 8400, Marketing Applications • SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)Effective Date: April 25, 2013

  11. Comment • Opportunity for comment for nearly all Regulations and Guidance • http://www.fda.gov/aboutfda/contactfda/commentonregulations/default.htm • Time • Form

  12. What’s your product? • Where is it regulated? • Center and Office differences in policy. • Toxicology • Differences in GMP • drugs v biologics v devices

  13. Public Meetings • Advisory Committees • Joint Industry • Joint Scientific • Part 15

  14. 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.

  15. 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.

  16. Organizations • BIO • DIA • Pharma • RAPS • FDLI • AdvaMed • MDMA • SOT • ASCO

  17. Organizations • Annual meetings • Joint Workshops • FDA-BIO

  18. Meetings hosted with Industry or Scientific Community • Usually on a specific issue • Industry Organizations • BIO • DIA • Pharma • NIH

  19. Services Distribution Lists • BIO Smartbrief • Daily • RAPS • Daily • LinkedIn forums • FDA

  20. Specific Product Reviews • Clinical • Pharmacology • CMC • Toxicologic • Statistical • Summary Basis for Approval

  21. EMA Reviews • EPAR: European Product Assessment Reports • Example: Humira, 243 pages

  22. Product Labels • What is there • What is not there

  23. Meetings with the FDA • Pre IND • IND • Pre Phase 3 • Pre BLA

  24. 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.

  25. Enforcement • 483s • warning letters • Untitled letters

  26. Consultants ! ?

More Related