1 / 45

16 th Annual NIH SBIR/STTR Conference

16 th Annual NIH SBIR/STTR Conference. F unctional D own-to-Earth A dvice for understanding the FDA Chris Sasiela, PhD, RAC NHLBI Office of Translational Alliances and Coordination. Learning Objectives. How the FDA is organized How drugs, biologics, and medical devices are regulated

ray-dorsey
Download Presentation

16 th Annual NIH SBIR/STTR Conference

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. 16th Annual NIH SBIR/STTR Conference Functional Down-to-Earth Advice for understanding the FDA Chris Sasiela, PhD, RAC NHLBI Office of Translational Alliances and Coordination

  2. Learning Objectives How the FDA is organized How drugs, biologics, and medical devices are regulated Where to start Where to go for help Office of Special Medical Programs

  3. Learning Objectives How the FDA is organized How drugs, biologics, and medical devices are regulated Where to start Where to go for help Office of Special Medical Programs

  4. FDA Organization http://www.fda.gov/downloads/AboutFDA/CentersOffices/OrganizationCharts/UCM291886.pdf

  5. Practical FDA for biomedical innovators

  6. Center for Biologics Evaluation and Research http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123224.htm

  7. Practical CBER for biomedical innovators Organized by therapeutic modality

  8. De-coding Biologics http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133072.htm

  9. Center for Drug Evaluation and Research http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm403687.htm

  10. Practical CDER for biomedical innovators Organized (generally) by disorder or organ system

  11. An ODE by any other name…

  12. Center for Devices and Radiological Health http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhoffices/ucm127854.htm CDRH Management Directory by Organization This information is current as of August 20, 2014. Office of the Center Director Office of Communication and Education Office of Compliance Office of Device Evaluation Office of In Vitro Diagnostics and Radiological Health Office of Management Operations Office of Science and Engineering Laboratories Office of Surveillance and Biometrics

  13. Practical CDRH for biomedical innovators Organized (generally) by disorder or organ system

  14. Medical Specialties

  15. Learning Objectives How the FDA is organized How drugs, biologics, and medical devices are regulated Where to start Where to go for help Office of Special Medical Programs

  16. Biologics Regulation • Regulated under the Public Health Service Act • IND for clinical development • Biologics License for marketing allowance • Co-regulate many medical devices • specifically related to blood products • ‘Biological Product'' • a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  17. Drug Regulation • Federal Food, Drug, and Cosmetic Act • as amended • Orphan Drug Act (1983) • Drug Price Competition and Patent Term Restoration Act (1984) • Best Pharmaceuticals for Children Act (2002) • Pediatric Research Equity Act (2003) • Food and Drug Administration Amendments Act (2007) • Food and Drug Administration Safety and Innovation Act (2012)

  18. Device Regulation • FD&C Act Medical Device Amendments • May 28, 1976 • Title 21 Code of Federal Regulations Parts 800-1299 • Classification based on risk • Class I Low Risk (General Controls) • Class II Medium Risk (General Controls and Special Controls) • Class III High Risk (General Controls and Premarket Approval) • Market allowance based on risk plus legislation • Exempt,510(k), PMA • Tracking • Establishment Registration • Medical Device Listing • Unique Device Identification

  19. Learning Objectives How the FDA is organized How drugs, biologics, and medical devices are regulated Where to start Where to go for help Office of Special Medical Programs

  20. www.FDA.gov

  21. FOIA Electronic Reading Rooms • CBER • http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm129132.htm • CDER • http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/ucm113237.htm • CDRH • http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHFOIAElectronicReadingRoom/default.htm

  22. CBER Product Approval Information Biologics Products & Establishments Licensed Biological Products with Supporting Documents Substantially Equivalent 510(k) Device Information Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs) New Drug Applications (NDAs) Postmarketing Requirements and Commitments: Introduction Transfer of Therapeutic Products to the Center for Drug Evaluation and Research

  23. Licensed Biological Products with Supporting Documents ALPROLIX (Biogen Idec)

  24. Types of Supporting Information/Documents BL 125444 Most current approval letter Rationale for approval In depth approval information!!

  25. Understanding CBER Licensing Applications Redacteddocuments How do reviewers think? How did the company present their product? (not all trials go into a license application) What was the company’s pre-clinical and clinical strategy?

  26. CDER Product Approval Information • Product Approval Information • Drugs @ FDA

  27. Basic Information ND 205434 In depth approval information!!

  28. What about the reviews? This product was approved on July 23, 2014. This screenshot was taken August 20, 2014. Redaction and uploading of review information takes time!

  29. CDRH Reading Room

  30. 510(k) Database K140582

  31. Product Information

  32. Product Classification Information

  33. 510(K) Summary Comparison to Predicate- Basis of SE determination Predicate Identification Device Description Sponsor Conclusions Intended Use

  34. FDA Educational Resources • CBER OCTGT Learn • http://www.fda.gov/biologicsbloodvaccines/newsevents/ucm232821.htm • CDER Learn • http://www.fda.gov/Training/ForHealthProfessionals/default.htm • CDRH Learn • http://www.fda.gov/Training/CDRHLearn/default.htm

  35. General Websites of Interest • FDA Small Business Guide • http://www.fda.gov/downloads/forindustry/smallbusinessassistance/smallbusinessguidetofda/ucm081030.pdf • FDA Small Business Contacts • http://www.fda.gov/forindustry/smallbusinessassistance/smallbusinessrepresentatives/ • FDA Information update request page • http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm#top

  36. Learning Objectives How the FDA is organized How drugs, biologics, and medical devices are regulated Where to start Where to go for help Office of Special Medical Programs

  37. Small Business Assistance Offices • CDER Small Business and Industry Assistance • CDERSmallBusiness@fda.hhs.gov (866) 405-5367 or (301) 796-6707 • CBER Office of Communication, Outreach, and Development • Industry.Biologics@fda.hhs.gov (800) 835-4709 or (301) 827-1800 • CDRH Division of Industry and Consumer Education • DICE@fda.hhs.gov (800) 638-2041 or (301) 796-7100

  38. Center Contact Information • CBER Contacts • http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123224.htm • CDER Contacts • http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm075128.htm • CDRH Contacts • http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm

  39. Learning Objectives How the FDA is organized How drugs, biologics, and medical devices are regulated Where to start Where to go for help Office of Special Medical Programs

  40. Cross-Center Offices

  41. Office of Combination Products • Guidance Documents • Early Development Considerations for Innovative Combination Products (09/2006) • How to Write a Request for Designation (04/2011) • Classification of Products as Drugs and Devices and Additional Product Classification Issues (Draft - 06/2011) combination@fda.hhs.gov 301-796-8930

  42. Orphan Product Development Programs • Designation Programs • Orphan Drug designation • including exclusivity • HUD Designation • Rare Pediatric Disease Designation • for Priority Review Voucher Program • Grants • Orphan Products Grants Program • Pediatric Device Consortia Grants Program • Outreach Program • Patient-related Topics

  43. Office of Orphan Product Development For (non-oncology) Orphan Drug Designations: Jeff.Fritsch@fda.hhs.gov For (oncology) Orphan Drug Designations, Devices, and Rare Pediatric Disease Designations: James.Bona@fda.hhs.gov For Orphan Grants: Mary.Limon@fda.hhs.gov For Pediatric Device Consortia Grants: Linda.Ulrich@fda.hhs.gov (301) 796-8660

  44. Office of Pediatric Therapeutics • Scientific Activities Program • Clinical protocol design/conduct/lessons-learned • Ethics Program • Necessity of proposed pediatric studies • Safety Program • Coordinate Pediatric Advisory Committee • International Program • Collaborate with other regulatory agencies OPT@fda.hhs.gov 301-796-8659

  45. Thank You ?

More Related