Useful FDA Resources

1. Useful FDA Resources Cynthia F. Kleppinger, M.D. Senior Medical Officer Division of Good Clinical Practice Compliance Office of Scientific Investigations 5 November 2012

2. “A Tour of FDA” Course Very interactive audio and visual training. Includes: FDA’s public health mission and how the Agency is organized to carry out its mission The history of the FDA and the products that it regulates FDA’s program Centers and offices, and how the Agency enforces its regulations http://www.kaplaneduneering.com/fileadmin/user/Multi-Media/FDA_demo_new/overview.htm

3. FDA Basics Includes monthly webinar series where different Centers and Offices host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. • Provides Information About FDA and What the Agency Does http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm

4. FDA Basics Recall Process for FDA-Regulated Products FDA's Pesticide Program Tissue Safety A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS) Access to Investigational Drugs The FDA’s Inspection Process Import Entry Process Adverse Event Reporting for Cosmetics • Past Webinar Examples

5. FDA Basics for Industry A Web resource to help companies and others save time and resources in their interactions with the agency Features questions, answers, videos, and other materials describing how the FDA works to protect and promote public health www.fda.gov/FDABasicsforIndustry

6. FDA Basics for Industry Examples of Resources Search Centers’ Databases Compliance and Enforcement Inspections Database Searchable Warning Letters Database FDA Debarment List Drugs FDA Adverse Event Report System (FAERS) Bioequivalence (BE) Recommendations for Specific Products Bioresearch Monitoring Information System (BMIS) Clinical Investigator Inspection List (CLIIL) Dissolution Methods Database Inactive Ingredient Search for Approved Drug Products Postmarket Requirements and Commitments Database

7. Site of Interest Sign up for Updates Get the latest news from FDA on topics of interest for all Centers. http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234630.htm

8. FDA E-Mail Updates Free e-mail subscription service. When you subscribe to this service, you will receive an e-mail message each time there is an update on the FDA page(s) you select. https://service.govdelivery.com/service/user.html?code=USFDA

9. CDERLearn • Web page for educational tutorials offered by the Center for Drug Evaluation and Research http://www.fda.gov/Training/ForHealthProfessionals/default.htm

10. CDERLearn Example • The Past, Present, and Future of FDA Human Drug Regulation • The overall goal of this activity is to give health professionals, regulated industry, consumers, and other participants a clear understanding of the changed world of FDA human drug regulation. Registration is required

11. The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

12. Development and Approval Process Links to: FDA’s regulations for the conduct of clinical trials and guidance documents Development resources Drug Development Tools Qualification Program http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm

13. Replies to Inquiries to FDA on Good Clinical Practice Designed to simplify the search for copies of e-mail messages (including the original inquiry and associated reply(ies)) that have been submitted by the public to the Good Clinical Practice Program's gcp.questions@fda.hhs.gov e-mail account. http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/RepliestoInquiriestoFDAonGoodClinicalPractice/default.htm

14. FDA Drug Info Rounds • Series of training videos for practicing clinical and community pharmacists Examples: drug shortages, approved and unapproved colchicine products, communicating drug safety messages • All videos are available at: • http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm211957.htm

15. Guidance Webinars • Aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders • An overview of the draft guidance Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ucm276211.htm

16. Guidance Webinar • New Draft Guidance on Safety Data Collection • March 27, 2012 webinar entitled "Determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations."  • http://www.fda.gov/Drugs/ucm296761.htm

17. Clinical Investigator Training Course Annual 3-day course targeted at medical professionals to help develop a cadre of well-trained investigators Includes lectures given by senior FDA experts and guest lecturers from industry and academia  Previous training materials available online. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIProjects/ucm201459.htm

18. FDA and MedscapeCollaborative Training • Transforming a Clinician Into an Investigator: What Does It Take? • Panel discussion moderated by Dr. Leonard Sacks, Acting Director, Office of Critical Path Programs at FDA • Clarifies the responsibilities of clinical investigators and address some of the challenges that investigators face today http://www.medscape.org/viewarticle/752701

19. Public Hearings • Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice Public Hearing • To obtain input on FDA's scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products. April 23-24, 2012 http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm?source=govdelivery then https://collaboration.fda.gov/p74599499/

20. Small Business Assistance For regulated domestic and international small pharmaceutical business seeking timely and accurate information relating to development and regulation of human drug products.  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm • Small Business Guide to FDA • http://www.fda.gov/ForIndustry/SmallBusinessAssistance/SmallBusinessGuidetoFDA/default.htm

21. Small Business Assistance ─Examples of Training Workshops and Webinars CDER Small Business Assistance: Clinical Trials Forum CDER's Small Business Assistance Educational Forum: The Investigational New Drug (IND) Process; Public Workshop FDA Small Pharmaceutical Business Assistance Educational Forum, Public Workshop Human Drug Export Compliance Webinar Import of Human Drugs and Human Drug Components Webinar Overview of the Drug Registration and Listing System (DRLS & eDRLS) Webinar Introduction to CDER’s Small Business Assistance Program Webinar DDI Webinar - Small Business Assistance - CDER 101 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm

22. FDA’s Transparency Initiative The FDA has created a web page to house all of the agency's key transparency activities so that these resources will be easier to find and use http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm

23. FDA-TRACK An online performance program for FDA offices nationwide Features monthly metrics for more than 100 agency offices and provides insight for the public into the FDA’s decision-making and regulatory activities. http://www.fda.gov/AboutFDA/Transparency/track/default.htm

24. Spotlight on Drug Innovation An ongoing update of FDA’s novel new drug approvals (new molecular entities) and work in CDER that advances regulatory science and innovation http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm

25. Generic Drugs: Information for Industry • News and Announcements • Generic Drug Approvals • List of Authorized Generic Drugs • Quality by Design (QbD)/Question based Review (QbR) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm?source=govdelivery

26. Product Search Search by Drug Name, Active Ingredient, or Application Number http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

27. Division of Drug Information CDER's focal point for public inquiries on human drug products and drug product regulation by FDA 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 Email: druginfo@fda.hhs.gov http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm082585.htm

28. For Health Professionals Expanded Access Webinar Acetaminophen Information Articles of Interest http://www.fda.gov/ForHealthProfessionals/default.htm

29. Articles of Interest The FDA produces written articles for a health professional audience. These include FDA News for Health Professionals articles, as well as articles that were published in health professional journals. http://www.fda.gov/ForHealthProfessionals/ArticlesofInterest/default.htm

30. FDA Safety Article • Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration Sonja Brajovic*, Toni Piazza-Hepp, Lynette Swartz, Gerald Dal Pan • Article first published online: 22 FEB 2012 http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1099-1557/earlyview

31. FDA Patient Safety News http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm?source=govdelivery

32. Drug Safety Communications Webpage contains the most recent Drug Safety Communications from FDA http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm As of July 18, 2011, you can find Spanish language versions at: http://www.fda.gov/Drugs/DrugSafety/ucm263010.htm

33. Drug Safety Podcasts • Provide emerging safety information about drugs in conjunction with the release of Public Health Advisories and other drug safety issues. http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm076703.htm

34. Communications Guidance • Draft guidance March 2012 Drug Safety Information -- FDA's Communication to the Public • Describes how CDER develops and disseminates messages about important drug safety issues, including emerging drug safety information http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295217.pdf

35. Drug Safety Oversight Board • Advises the CDER Center Director on the handling and communicating of important and often emerging drug safety issues. • Public summaries of all meetings http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm082136.htm

36. Inspections, Compliance, Enforcement, and Criminal Investigations

37. Chapter 1 - Regulatory Organization  Chapter 2 - FDA Authority  Chapter 3 - Commissioning and Work Sharing  Chapter 4 - Advisory Actions  Chapter 5 - Administrative Actions Chapter 6 - Judicial Actions  Chapter 7 - Recall Procedures  Chapter 8 - Emergency Procedures  Chapter 9 - Import Operations and Actions  Chapter 10 - Other Procedures  Chapter 11 - Glossary  Appendix  Chapter Summary http://www.fda.gov/ICECI/compliancemanuals/regulatoryproceduresmanual/default.htm

38. Compliance Programs Clinical Investigator Sponsor/Monitor/Contract Research Organization Institutional Review Board Radioactive Drug Research Committee In Vivo Bioequivalence Good Laboratory Practice (Nonclinical Laboratories Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit Inspections http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ucm255614.htm

39. Compliance & Enforcement • Links to information about clinical investigators who have and/or are participating in clinical trials of pharmaceutical products as well as regulatory correspondence and restrictions resulting from noncompliance observed during bioresearch monitoring (BIMO) inspections. • Clinical Investigator Inspection List, Bioresearch Monitoring Information Systems (BMIS) files, Warning Letters, NIDPOE Letters, Lists of Disqualified or Restricted or Debarred Investigators, Code of Federal Regulations, etc. http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplianceEnforcement/default.htm

40. Compliance Information http://www.fda.gov/ICECI/default.htm

41. Guidances of Interest FDA Inspections of Clinical Investigators- Information sheet http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126553.pdf Guidance for Industry-Investigator Responsibilities http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf

42. Guidances of Interest Statement of Investigator (Form FDA 1572) Information Sheet http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf Guidance for Industry - Acceptance of Foreign Clinical Studies http://www.fda.gov/RegulatoryInformation/Guidances/ucm124932.htm

43. Guidances of Interest • Guidance for Industry and FDA Staff- Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions March 2012 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

44. Reference of Interest White Paper: FDA Inventory of Clinical Trials Protocols and Clinical Study Data 8/31/2011 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/UCM309552.pdf

45. FDA International Agreements Confidentiality Commitments http://www.fda.gov/InternationalPrograms/Agreements/ConfidentialityCommitments/default.htm Memoranda of Understanding and Other Cooperative Arrangements http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/default.htm 45

46. www.fda.gov

47. Thank you