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Beers Block, B.S., B.S., CCRP Assistant Professor Biopharma Educational Initiative BPHE6800P Regulatory Writing for Submissions and Publications Lesson: New Drug Applications, Part 2Recap NDA Lecture, Part 1 : Recap NDA Lecture, Part 1 Regulatory requirements Content and Format : 21 CFR 314.50 Required reports: 21 CFR 314. , , Need to consider additional information PDUFA, FDAA, ICH documents This lecture extends “requirements” to global structure outlined in ICH M2 & M4FDA Laws: FDA Laws FDAAA & PDUFAPrescription Drug User Fee Act (IV): Prescription Drug User Fee Act (IV)PDUFA IV (until end of 2012): PDUFA IV (until end of 2012) Law that establishes binding commitments for FDA and industry re: performance standards for IND and NDA meetings, and review of NDAs Briefly: Created a more robust post-market drug safety system ; establishes REMs; establishes performance standards and filing fees FDA summary of PDUFA IV, available at: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM207568.pdfPDUFA Details: PDUFA Details FDA Reports and commitments available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm209456.htm Additional information is also available on the FDA User Fees web page http://www.fda.gov/ForIndustry/UserFees/default.htmPDUFA Guidance: PDUFA Guidance Classifying Resubmissions in Response to Action Letters Fees-Exceed-the-Costs Waivers Under the Prescription drug User Fee Act Submitting and Reviewing Complete Responses to Clinical Holds Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing FeesProposed PDUFA V: Proposed PDUFA V Good idea to become familiar with this proposal. You can find it at: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM287747.pdf Submitted to Congress this month Highlight: PDUFA V will require electronic submissions of applications (see lines 451-467, pg. 11 of PDUFA V Statutory Language )PDUFA Goals (2013-2017): PDUFA Goals (2013-2017) Review Performance Goals Major Dispute Resolution Clinical Holds Special Protocol Question Assessment and Agreement Meeting Management Goals Enhancing Regulatory Science Enhancing Benefit-Risk Assessment in Regulatory ReviewPowerPoint Presentation: Enhancement/Modernization of Drug Safety System (e.g., Sentinel) Require Electronic Submissions Information Technology GoalsFood and Drug Administration Amendment Act of 2007: Food and Drug Administration Amendment Act of 2007 FDAAAREMS become Statutory Requirement: REMS become Statutory Requirement Changes made to FDA’s law (FDAAA) in 2007 resulted in additional provisions for evaluating the safety of marketed products FDA may require the submission of a “Risk Evaluation and Mitigation Strategy” (REMS) under Section 909 of FDAAA REMS are intended to ensure the benefits outweigh the risks of the drugREMS Information: REMS Information FDA published a list of approved products that needed proposed REMS 73 FR 16313, March 27, 2008; Available at: http://www.gpo.gov/fdsys/pkg/FR-2008-03-27/pdf/E8-6201.pdf REMS draft guidance Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf REMSPost Market Requirements FDAAA 901: Post Market Requirements FDAAA 901 Guidance issued March 2011. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf Can periodically report on PMR that are to evaluate safety of product in annual report (21 CFR 314.81) Does NOT include REMSICH Guidances: ICH GuidancesBest Practices: Best Practices Submit required data using ICH formats described in various ICH Mx Common Technical Document guidances : M4: Organization of CTC M4Q: The CTD — Quality M4S: The CTD — Safety M4E: The CTD — Efficacy M2 : eCTD – Electronic Common Tech.DocCTD Overview: CTD Overview Module Information Administrative and prescribing information (region specific) 2 Summaries and overview 3 Information on product quality 4 Nonclinical study reports 5 Clinical study reportsCTD Overview: CTD Overview Module 1: Administrative Information and Prescribing Information 1.1 Table of Contents of the Submission Including Module 1 1.2 Documents Specific to Each Region (for example, application forms, prescribing information) Module 2: Common Technical Document Summaries 2.1 CTD Table of Contents 2.2 CTD Introduction 2.3 Quality Overall Summary 2.4 Nonclinical Overview 2.5 Clinical Overview 2.6 Nonclinical Written and Tabulated Summary Pharmacology Pharmacokinetics Toxicology 2.7 Clinical Summary Biopharmaceutics and Associated Analytical Methods Clinical Pharmacology Studies Clinical Efficacy Clinical Safety Synopses of Individual StudiesCTD Overview: CTD Overview Module 3: Quality 3.1 Module 3 Table of Contents 3.2 Body of Data 3.3 Literature References Module 4: Nonclinical Study Reports 4.1 Module 4 Table of Contents 4.2 Study Reports 4.3 Literature References Module 5: Clinical Study Reports 5.1 Module 5 Table of Contents 5.2 Tabular Listing of All Clinical Studies 5.3 Clinical Study Reports 5.4 Literature ReferencesPowerPoint Presentation: This guidance is available at : http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080589.pdf “General Considerations” Draft GuidancePowerPoint Presentation: * See pages 12-24 of this guidance. It is available at FDA’s website: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163175.pdf Comprehensive Table of Contents Headings and Hierarchy*PowerPoint Presentation: See pages 12-24Helpful FDA Guidances: Helpful FDA Guidances M4 Organization of CTD ( August 2001) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073257.pdf M4Q The CTD-Quality (August 2001) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073280.pdf M4S: The CTD- Safety (August 2001) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073299.pdf M4E: The CTD- Efficacy (August 2011) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073290.pdfHelpful FDA Guidances: Helpful FDA Guidances M4 CTD General Questions & Answers http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073276.pdf M4 CTD Quality Questions & Answers http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073285.pdf M4 CTD Safety Questions & Answers http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073303.pdf M4 CTD Efficacy Questions & Answers http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073293.pdfHelpful FDA Guidances: Helpful FDA Guidances M4 Granularity Document Annex to M4: Organization of the CTD (October 2005) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073261.pdf M2 eCTD : Electronic Common Technical Document http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073240.pdfAdditional Helpful FDA Guidances +: Additional Helpful FDA Guidances + Bioavailability and Bioequivalence Studies for Orally Administered Drug Products- General Considerations Changes to an Approved NDA or ANDA (11/1999) Changes to an Approved NDA or ANDA: Questions and Answers (1/2001)Helpful Guidances (cont): Helpful Guidances (cont) Container Closure Systems for Packaging Human Drugs and Biologics (5/1999) Format and Content of the Microbiology Section of an Application Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances Submitting Samples and Analytical Data for Methods Validation Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products NDAs: Impurities in Drug Substances (2/2000) Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (2/1987)Helpful Guidances (cont): Helpful Guidances (cont) Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application (Posted 3/2/1998) Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products Drug Master Files Required Specifications for FDA's IND, NDA, and ANDA Drug Master File Binders Qualifying for Pediatric Exclusivity PET Drug Applications - Content and Format for NDAs and ANDAs (3/7/2000) Refusal to File (7/12/1993) + New Drug Application (Internet). US FDA (January 2, 2012). Available from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htmFDA/ICH Guidances ++: FDA/ICH Guidances ++ Q1(A) Stability of New Drug Substances Q1(B) Photostability of New Drug Substances and Products Q1(C) Stability Testing for New Drug Dosage Forms Q2 Validation of Standards Q3(…) Impurities… Q6(…) SpecificationsFDA/ICH Guidances (cont): FDA/ICH Guidances (cont) Q7 GMP for Active Pharmaceuticals Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality SystemFDA/ICH Guidances (cont): FDA/ICH Guidances (cont) E2(…) Clinical Safety Data Management E3 Structure and Content of Clinical Study Reports E9 Statistical Principles for Clinical Trials M2(…) eCTD M3 Non-clinical Safety StudiesFDA/ICH Guidances (cont): FDA/ICH Guidances (cont) S1(…) Carcinogenicity … S2(…) Genotoxicity … S3(A) Toxicokinetics … S3(B) Pharmacokinetics … S4-9 Additional testing recommendations ++ ICH Guidances [Internet]; US FDA. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065007.htmIn Summary-: In Summary- NDA submissions must contain information that allows regulatory authority to make an assessment of the safe and effective use of a drug product that is intended for market Information should be tailored to the particulars of the study Following current regulatory requirements and FDA/ICH guidancesBPHE6800P: BPHE6800P Thank you for your kind attention! You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.