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First Clinical Research Laws, Regulations & Guidelines


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 FDA & OHRP Guidance – Exculpatory Language in Informed Consent 
 FDA – Delegation of Authority 
 FDA – Informed Consent FAQs 
 FDA - List of Guidance Documents 2008 
 FDA - Monitoring Postmarketing Study Commitments 
 FDA - Physician Request for a Single Patient IND  
 FDA – Privacy Act – Exempt Record System (Proposed Rule) 
 FDA – Privacy Act of 1974 – FDA Records Related to Research Misconduct Proceedings 
 FDA – Providing Submissions in Electronic Format – Summary Level Clinical Site Data for CDER’s Inspection Planning (Draft) 
 FDA - Report on Postmarketing Study Commitments 2006 
 FDA CDER – MAPP 5210.7 – Inspections of Clinical Facilities and Analytical Laboratories 
 FDA CDER – MAPP 6010.2 – Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments 
 FDA CDER – MAPP 6010.9 – Postmarketing Commitments Procedures and Responsibilities 
 FDA Certificate of Confidentiality Application Instructions  
 FDA Filing – 21 CFR 50.25 – Informed Consent Elements Final Rule 
 FDA Filing - Charging for Investigational Drugs Under an IND 
 FDA Filing - IRB Registration 
 FDA Filing - Patient Safety and Quality Improvement 
 FDA Final Rule - Investigational New Drugs: Export Requirements for Unapproved New Drug Products Final Rule 
 FDA Guidance – Adaptive Design Clinical Trials (Draft) 
 FDA Guidance - Adverse Event Reporting to IRBs 
 FDA Guidance - Available Therapy 
 FDA Guidance - BA and BE Testing Samples 
 FDA Guidance – Bayesian Statistics in Medical Device Clinical Trials 
 FDA Guidance – Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications 
 FDA Guidance - Centralized IRBs (Draft) 
 FDA Guidance - CGMP for Phase 1 Investigational Drugs 
 FDA Guidance – Charging for Investigational Drugs Under an IND – Q&A (Draft) 
 FDA Guidance - Clinical Evidence of Effectiveness 
 FDA Guidance – Clinical Holds 
 FDA Guidance – Clinical Pharmacogenomics: Premarket Evaluation 
 FDA Guidance – Clinical Pharmacogenomics: Premarketing Evaluation (Draft) 
 FDA Guidance - Clinical Studies Section of Labeling 
 FDA Guidance - Clinical Trial Data Monitoring Committees (Draft) 
 FDA Guidance - Clinical Trial Endpoints - Cancer Drugs (Draft) 
 FDA Guidance – Clinical Trial Endpoints for Cancer 
 FDA Guidance – Clinical Trial Imaging Endpoints (Draft) 
 FDA Guidance – Codevelopment of Investigational Drugs for Use in Combination 
 FDA Guidance – Computerized Systems in Clinical Investigations 
 FDA Guidance – Considerations When Transferring Clinical Investigation Oversight to Another IRB (Draft) 
 FDA Guidance – Control Groups (E10) 
 FDA Guidance - Data Monitoring Committees 
 FDA Guidance - Data Retention When Subjects Withdraw from Trials 
 FDA Guidance – Determining if Study Requires IND 
 FDA Guidance – Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (Draft) 
 FDA Guidance – Determining Whether Human Research Studies Can Be Conducted Without an IND 
 FDA Guidance - Drug Master File Binders 
 FDA Guidance – Electronic Records (Part 11) 
 FDA Guidance – Electronic Source Data in Clinical Investigations 
 FDA Guidance – Electronic Source Documentation in Clinical Investigations (Draft) 
 FDA Guidance – Emergency Research (Draft) 
 FDA Guidance - End of Phase 2A Meetings 
 FDA Guidance – Enrichment Strategies for Clinical Trials (Draft) 
 FDA Guidance – Evaluation of Drugs in Infants and Children 
 FDA Guidance - Exemptions of Drugs for Treatment of Cancer 
 FDA Guidance – Expanded Access to Investigational Drugs for Treatment Use – Q&A (Draft) 
 FDA Guidance – Expedited Programs for Serious Conditions – Drugs and Biologics (Draft) 
 FDA Guidance – Exploratory IND Studies 
 FDA Guidance - Fast Track Drug Development 
 FDA Guidance – FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND - FAQs 
 FDA Guidance – FDA Inspections of Clinical Investigators 
 FDA Guidance – Financial Disclosure by Clinical Investigators 
 FDA Guidance – Food Effect Bioavailability 
 FDA Guidance - Frequently Asked Questions about IRB Registration 
 FDA Guidance - General Considerations for Clinical Evaluation of Drugs 
 FDA Guidance – Gene Therapy – Delayed Adverse Events 
 FDA Guidance – Geriatric Studies 
 FDA Guidance - Good Clinical Practice (E6) 
 FDA Guidance – HIPAA Authorizations 
 FDA Guidance – ICH M3(R2) Nonclinical Safety Studies (Draft) 
 FDA Guidance – IDEs for Early Feasibility Medical Device Clinical Studies (Draft) 
 FDA Guidance - Inspections of Clinical Investigators 
 FDA Guidance - Institutional Review Boards 
 FDA Guidance - Integrated Summary of Effectiveness (Draft) 
 FDA Guidance - Investigator Inspections 
 FDA Guidance – IRB Approval of Research with Conditions 
 FDA Guidance – IRB Continuing Review 
 FDA Guidance – IRB Continuing Review after Clinical Investigation Approval (Draft) 
 FDA Guidance - IRB Inspections 
 FDA Guidance – IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed 
 FDA Guidance - Medical Devices 
 FDA Guidance – Monitoring of Clinical Investigations (Withdrawn) 
 FDA Guidance – Non-Inferiority Clinical Trials (Draft) 
 FDA Guidance – Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring 
 FDA Guidance – Patient-Reported Outcome Measures 
 FDA Guidance – Pediatric Equity Act 
 FDA Guidance - Pediatric Pharmacokinetic Studies 
 FDA Guidance – Personal Importations 
 FDA Guidance - Pharmacogenomic Data 
 FDA Guidance - Pharmacogenomic Data Submissions - Draft 
 FDA Guidance - Pharmacovigilance 
 FDA Guidance – Pivotal Clinical Investigations for Medical Devices (Draft) 
 FDA Guidance – Postmarketing Studies – Implementation of Section 505(o)(3) 
 FDA Guidance - Premarket Assessment of Pediatric Medical Devices (Draft) 
 FDA Guidance – Premarketing Risk Assessment 
 FDA Guidance - Preparation of Investigational New Drug Products 
 FDA Guidance – Procedures for Handling Section 522 Postmarket Surveillance Studies (Draft) 
 FDA Guidance – Protecting the Rights, Safety, and Welfare of Study Subjects 
 FDA Guidance – Q&A on Informed Consent Elements 
 FDA Guidance – Qualification Process for Drug Development Tools (Draft) 
 FDA Guidance - Referrals to FDA - Safeguards for Children - Draft 
 FDA Guidance – Regulatory Submissions in Electronic Format – Standardized Study Data (Draft) 
 FDA Guidance – Risk Evaluation and Mitigation Strategies (Proposed)  
 FDA Guidance – Risk Minimization Action Plans 
 FDA Guidance – Safety Reporting for INDs and BA/BE Studies 
 FDA Guidance – Safety Reporting Requirements for INDs and BA/BE Studies 
 FDA Guidance – Serious Diseases 
 FDA Guidance – Supervisory Responsibilities of Investigators (Draft) 
 FDA Guidance - Target Product Profile 
 FDA Guidance – Terminology in Pharmacogenomics (ICH E15) (Draft) 
 FDA Guidance – Transferring Clinical Investigation Oversight to Another IRB (Draft) 
 FDA Guideline – Drug Master Files 
 FDA Guideline – Structure and Content of Clinical Study Reports (E3) 
 FDA Information Sheet – Clinical Investigator Disqualification 
 FDA Information Sheet - Continuing Review 
 FDA Information Sheet - Cooperative Research 
 FDA Information Sheet – Emergency Use 
 FDA Information Sheet - Exception from Informed Consent 
 FDA Information Sheet - FAQs 
 FDA Information Sheet – FDA vs. HHS Regulations 
 FDA Information Sheet – For 1572 Frequently Asked Questions 
 FDA Information Sheet - Informed Consent 
 FDA Information Sheet – Inspections of Clinical Investigators 
 FDA Information Sheet - Investigational Use Of Marketed Drugs 
 FDA Information Sheet – Investigator Sanctions 
 FDA Information Sheet – Medical Device FAQs 
 FDA Information Sheet - Non-Local IRB Review 
 FDA Information Sheet – Risk of Medical Device Studies 
 FDA Information Sheet – Second Institution 
 FDA Information Sheet – Selected FDA Regulations 
 FDA Information Sheet - Self-Evaluation Checklist for IRBs 
 FDA Information Sheet - Sponsor-Investigator-IRB Interrelationship 
 FDA Information Sheet – Waiver of IRB Requirements 
 FDA Investigations Operation Manual – Subchapter 5.5 - Drugs 
 FDA Investigations Operation Manual – Subchapter 5.6 – Biologics 
 FDA Investigations Operation Manual – Subchapter 5.6 – Devices 
 FDAMA - Women and Minorities Guidance 
 FDA Manual – Attachment A: Annotated Clinical Review Template 
 FDA Manual – Attachment B: Clinical Safety Review of an NDA or BLA 
 FDA Manual – Bioresearch Monitoring 
 FDA Manual – Good Review Practice: Clinical Review Template 
 FDA Proposed Rule – Disqualification of a Clinical Investigator 
 FDA Proposed Rule – Reporting Information Regarding Falsification of Data 
 FDA Revised Rule - Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application 
 FDA Rule – Disqualification of a Clinical Investigator 
 FDA Rule – Safety Reporting for Investigational New Drugs and Biological Products 
 FDA Staff Manual Guide – Investigator Disqualification Hearing Process 
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