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 CDER – MAPP 6030.2 – Review of Informed Consent Documents 
 FDA CDER – MAPP 6030.8 Rev 1 – INDs: Exception From Informed Consent Requirements for Emergency Research 
 FDA Certificate of Confidentiality Application Instructions  
 FDA Fact Sheet – Single Patient Expanded Access: Physician Fact Sheet and Application Checklist 
 FDA Fact Sheet – Single Patient Expanded Access: What You Need to Know 
 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  
 FDA Guidance – Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (Draft) 
 FDA Guidance – Adaptive Design Clinical Trials (Draft) 
 FDA Guidance – Adaptive Designs for Medical Device Clinical Studies 
 FDA Guidance – Adaptive Designs for Medical Device Clinical Studies (Draft) 
 FDA Guidance – Adverse Event Reporting  
 FDA Guidance – Applying Human Factors and Usability Engineering to Medical Devices 2016 
 FDA Guidance – Available Therapy 
 FDA Guidance – BA and BE Testing Samples 
 FDA Guidance – Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval 
 FDA Guidance – Bayesian Statistics in Medical Device Clinical Trials 
 FDA Guidance – Benefit-Risk Determinations for IDEs (Draft) 
 FDA Guidance – Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications 
 FDA Guidance – Best Practices for Communication between IND Sponsors and FDA During Drug Development (Draft) 
 FDA Guidance – Best Practices for Communication Between IND Sponsors and FDA During Drug Development (Draft) 
 FDA Guidance – Categorization of Investigational Device Exemption (IDE) Devices to Assist CMS with Coverage Decisions (draft) 
 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 – Charging for Investigational Drugs Under an IND Q&A 
 FDA Guidance – Clinical Evidence of Effectiveness 
 FDA Guidance – Clinical Holds 
 FDA Guidance – Clinical Pharmacogenomics: Premarket Evaluation 
 FDA Guidance – Clinical Studies Section of Labeling 
 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 –Communication Between IND Sponsors and FDA(Draft) 
 FDA Guidance – Computerized Systems in Clinical Investigations 
 FDA Guidance – Considerations When Transferring Clinical Investigation Oversight to Another IRB 
 FDA Guidance – Control Groups (E10) 
 FDA Guidance – Critical Path Innovation Meetings 
 FDA Guidance – Data Monitoring Committees 
 FDA Guidance – Data Retention When Subjects Withdraw from Trials 
 FDA Guidance – Decisions for IDE Clinical Investigations 
 FDA Guidance – Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations 
 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 – eCopy Program for Medical Device Submissions 
 FDA Guidance – eCopy Program for Medical Device Submissions 
 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 (Draft) 
 FDA Guidance – Enrichment Strategies for Clinical Trials (Draft) 
 FDA Guidance – Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies (Draft) 
 FDA Guidance – Evaluation of Drugs in Infants and Children 
 FDA Guidance – Evaluation of Sex-Specific Data in Medical Device Studies 
 FDA Guidance – Exception from Informed Consent Requirements for Emergency Research 
 FDA Guidance – Expanded Access to Investigational Drugs for Treatment Use – Q&A (Draft) 
 FDA Guidance – Expanded Access to Investigational Drugs for Treatment Use Q&A 
 FDA Guidance – Expedited Access for Premarket Approval and De Novo Medical Devices 
 FDA Guidance – Expedited Programs for Serious Conditions – Drugs and Biologics 
 FDA Guidance – Exploratory IND Studies 
 FDA Guidance – Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions (Draft) 
 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 – Highest Priority Devices for Human Factors Review (Draft) 
 FDA Guidance – HIPAA Authorizations 
 FDA Guidance – ICH M3(R2) Nonclinical Safety Studies (Draft) 
 FDA Guidance – IDEs for Early Feasibility Medical Device Clinical Studies 
 FDA Guidance – IND Exemptions of Drugs for Treatment of Cancer 
 FDA Guidance – Individual Patient Expanded Access Applications: Form FDA 3926 
 FDA Guidance – Individual Patient Expanded Access Applications: Form FDA 3926 
 FDA Guidance – Individual Patient Expanded Access Applications: Form FDA 3926 (Draft) 
 FDA Guidance – Individual Patient Expanded Access Applications: Form FDA 3926 (Draft) 
 FDA Guidance – Informed Consent Information Sheet (Draft) 
 FDA Guidance – Inspections of Clinical Investigators 
 FDA Guidance – Institutional Review Board Inspections 
 FDA Guidance – Institutional Review Boards 
 FDA Guidance – Integrated Summary of Effectiveness (Draft) 
 FDA Guidance – Investigational New Drug Applications by Sponsor-Investigators (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 Meeting Minutes (Draft) 
 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 – IRB Written Procedures: Guidance for Institutions and IRBs (Draft) 
 FDA Guidance – Meaning of “Spouse” and “Family” in FDA’s Regulations – Q & A 
 FDA Guidance – Medical Devices 
 FDA Guidance – Monitoring of Clinical Investigations 
 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 – Pharmacovigilance 
 FDA Guidance – Pivotal Clinical Investigations for Medical Devices 
 FDA Guidance – Pivotal Clinical Investigations for Medical Devices 
 FDA Guidance – Postmarketing Studies – Implementation of Section 505(o)(3) 
 FDA Guidance – Premarket Assessment of Pediatric Medical Devices 
 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 Assessment for IND Safety Reporting (Draft) 
 FDA Guidance – Safety Assessment for IND Safety Reporting (Draft) 
 FDA Guidance – Safety Reporting for INDs and BA/BE Studies 
 FDA Guidance – Safety Reporting Requirements 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 Guidance – Use of Electronic Health Record Data in Clinical Investigations 
 FDA Guidance – Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers (Draft) 
 FDA Guidance – Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a Risk Management Process 
 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 Manual – Institutional Review Board Inspections 
 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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