Drugs 110
- Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)
- Predetermined Change Control Plans for Artificial Intelligence and Machine Learning-Enabled Device Software Functions
- Long-Term Neurodevelopmental Safety Evaluation of Medical Products Used in Neonates
- User Fees for Combination Products and Associated Waivers
- Use-Related Risk Analysis for Drug, Biological, and Combination Products: Determining Human Factors Study Needs (DRAFT)
- Essential Drug Delivery Outputs for Drug Delivery Devices and Combination Products (DRAFT)
- Diversity in Clinical Trials: Enrollment Goals and Action Plans for Underrepresented Racial, Ethnic, Sex and Age Groups (DRAFT)
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT)
- Remote Regulatory Assessments for FDA-Regulated Products and Establishments (DRAFT)
- Translation of Non-English Good Laboratory Practice (GLP) Study Reports (DRAFT)
- Development of Products for Prevention and Treatment of Acute and Chronic Graft-Versus-Host Disease (DRAFT)
- Human Factors Studies and Related Analyses for Combination Products
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Content of Premarket Submissions for Device Software Functions
- Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies
- Risk-Based Monitoring of Clinical Investigations
- Process for Research Involving Children that Requires FDA and OHRP Review under 21 CFR 50.54 and 45 CFR 46.407 (DRAFT)
- Clinical Investigator Disqualification Procedures and Administrative Actions
- Clinical Decision Support Software Functions: Criteria for Non-Device Classification and Implementation Requirements
- Ethical Considerations for Clinical Investigations of Medical Products in Children (DRAFT)
- Compliance Requirements for Ophthalmic Drug-Device Combination Products Following Genus Decision
- Including Older Adults in Cancer Clinical Trials: Design and Conduct Considerations
- Premarket Review Pathways for Combination Products
- Histopathology Peer Review in Nonclinical Toxicology Studies
- Safety Reporting Requirements for Clinical Investigators in IND and IDE Studies (DRAFT)
- Export Certification Process and Requirements for FDA-Regulated Products
- In Vitro Testing and Labeling for Oral Drug Products Administered via Enteral Feeding Tubes (DRAFT)
- Implementation of ICH Q12 Tools and Enablers for Post-Approval CMC Changes in Drug Products and Combination Products (DRAFT)
- Obtaining FDA Feedback for Combination Products: Best Practices and Meeting Procedures
- Certificates of Confidentiality for Non-Federally Funded Research: Protection of Human Subject Privacy in FDA-Regulated Studies
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Home Use
- Civil Money Penalties Related to ClinicalTrials.gov Requirements
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- Reliability Requirements for Emergency-Use Auto-Injectors (DRAFT)
- Developing and Labeling Companion Diagnostics for Multiple Oncology Therapeutic Products
- Safety Considerations for Flow Restrictors in Oral Liquid Drug Products to Prevent Accidental Ingestion by Children (DRAFT)
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
- Bridging Strategies for Drug-Device and Biologic-Device Combination Products (DRAFT)
- Postmarketing Safety Reporting Requirements for Combination Products
- Technical Specifications for Next Generation Sequencing Data in Antiviral Drug Development
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
- Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests
- Public Warning and Notification of Recalls Under Part 7
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
- Impact of Revised Common Rule on FDA-Regulated Clinical Investigations
- Selection of Package Type Terms and Discard Statements for Injectable Medical Products
- Heparin in Medical Devices and Combination Products: Testing, Labeling and Safety Requirements
- Medical Product Communications That Are Consistent With FDA-Required Labeling
- Health Care Economic Information Communications to Payors for Medical Devices
- Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
- Standards for Drug Supply Chain Transaction Information, History and Statements (DRAFT)
- How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
- Investigational In Vitro Diagnostic Devices Used in Therapeutic Product Clinical Trials (DRAFT)
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Classification of Products as Drugs or Devices: Interpretation and Determination Process
- Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
- Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses
- Current Good Manufacturing Practice Requirements for Combination Products
- Use of Electronic Informed Consent in Clinical Investigations
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- In Vitro Companion Diagnostic Device and Therapeutic Product Co-Development (DRAFT)
- Evaluating Appearance Issues and Granting Participation Authorizations for Advisory Committee Members (DRAFT)
- Meetings with the Office of Orphan Products Development: Procedures and Best Practices
- Recommendations for Labeling Medical Products Without Natural Rubber Latex
- In Vitro Companion Diagnostic Devices: Development, Review Process, and Labeling Requirements
- Considering Whether FDA-Regulated Products Involve Nanotechnology
- Transfer of Clinical Investigation Oversight Between Institutional Review Boards
- Same-Sex Marriage Recognition in Regulatory Definitions of Spouse and Family
- Public Disclosure of Advisory Committee Members' Financial Interests and Waivers
- Electronic Source Data in Clinical Investigations
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Risk-Based Monitoring in Clinical Investigations of Medical Products
- Technical Considerations for Pen, Jet, and Related Injectors Submitted in Drug and Biological Product Applications
- Public Participation in Open Public Hearing Sessions of Advisory Committee Meetings
- Exception from Informed Consent Requirements for Emergency Research
- Glass Syringes: Testing and Performance Requirements for Connectivity with Needles and Other Devices (DRAFT)
- Financial Disclosure Requirements for Clinical Investigators
- Postapproval Changes to Combination Products: Marketing Submission Requirements (DRAFT)
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- Exculpatory Language in Informed Consent Documents for Clinical Research (DRAFT)
- How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment
- Adding Imaging Contrast Indications to Medical Devices Used with Approved Imaging Drugs
- Patient-Reported Outcome Measures: Development, Implementation and Evaluation in Clinical Trials
- Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
- IRB Registration Requirements and Procedures
- Color Additive Petitions: Chemical and Technical Requirements for Food, Drugs, Cosmetics, and Medical Devices
- Adverse Event Reporting to IRBs Under FDA-Regulated Research
- Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
- Voting Procedures for Advisory Committee Meetings
- Preparation and Submission of Advisory Committee Briefing Materials for Public Release
- Container and Closure System Integrity Testing as an Alternative to Sterility Testing for Stability Protocols
- Jurisdictional Determinations for HCT/P Processing Devices: CBER vs CDRH Assignment
- Regulatory Framework for Complementary and Alternative Medicine Products (DRAFT)
- Process for Clinical Investigations Involving Children Requiring Additional Safeguards
- Early Development Considerations for Combination Products
- Establishment and Operation of Clinical Trial Data Monitoring Committees
- Electronic Distribution of Product Information and Safety Communications
- Pharmacogenetic Tests: Premarket Submission Requirements and Performance Validation
- Electronic Submission Format Requirements for Orphan Drug and Humanitarian Use Device Designation Requests (DRAFT)
- Pharmacogenomic Data Submissions in Drug Development and Biomarker Classification
- Dispute Resolution Process for Combination Product Review Timelines
- Electronic Records and Electronic Signatures - Scope and Application
- Categories of Research Eligible for Expedited IRB Review
- Industry-Supported Scientific and Educational Activities: Maintaining Independence from Promotional Influence
- Direct Final Rulemaking Procedures and Implementation Process
- Maintaining Independence of Industry-Supported Scientific and Educational Activities
- Export Requirements for Products Not Approved for Sale in the United States
- Reinspection of Firms During Pending Legal Actions
- Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies