Guidances directory

All guidance documents2,320 total

• Container Closure Systems for Human Drugs and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut ProduceGuidance Document · Human Foods Program
• Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent PartsGuidance Document · Center for Drug Evaluation and Research
• Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
• Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
• Cancer Clinical Trial Eligibility Criteria: Performance Status: Guidance for Industry, IRBs, and Clinical InvestigatorsGuidance Document · Office of the Commissioner
• Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) TrialsGuidance Document · Center for Drug Evaluation and Research
• Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a DrugGuidance Document · Center for Drug Evaluation and Research
• Forms FDA 3542a and FDA 3542: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Certain Postapproval Requirements and Resources for ANDAsGuidance Document · Center for Drug Evaluation and Research
• Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome EditingGuidance Document · Center for Biologics Evaluation and Research
• Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Draft GuidanceGuidance Document · Office of the Commissioner
• Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of ProteinGuidance Document · Human Foods Program
• Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket AuthorizationGuidance Document · Center for Tobacco Products
• Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Submitting Continuous Glucose Monitoring Data in Clinical TrialsGuidance Document · Center for Biologics Evaluation and Research
• Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #91 (VICH GL8 (R)) Stability Testing for Medicated Premixes (Revision 1)Guidance Document · Center for Veterinary Medicine
• Establishing Impurity Specifications for AntibioticsGuidance Document · Center for Drug Evaluation and Research
• Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation SequencingGuidance Document · Center for Biologics Evaluation and Research
• Bioanalytical Method Validation for BiomarkersGuidance Document · Center for Drug Evaluation and Research
• General Considerations for the Use of New Approach Methodologies in Drug Development: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for IndustryGuidance Document · Center for Tobacco Products
• Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP InspectionGuidance Document · Center for Drug Evaluation and Research
• New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological CauseGuidance Document · Center for Biologics Evaluation and Research
• Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Draft Guidance for IndustryGuidance Document · Human Foods Program
• Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing AnimalsGuidance Document · Center for Veterinary Medicine
• Certification Process for Designated Medical Gases: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• E22 General Considerations for Patient Preference StudiesGuidance Document · Center for Drug Evaluation and Research
• Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• FDA Records Access Authority for Cosmetic Products: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: QualityGuidance Document · Center for Drug Evaluation and Research
• Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for IndustryGuidance Document · Office of Inspections and Investigations
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for IndustryGuidance Document · Office of Inspections and Investigations
• Study Data Technical Conformance Guide - Technical Specifications DocumentGuidance Document · Center for Drug Evaluation and Research
• ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Study of Sex Differences in the Clinical Evaluation of Medical ProductsGuidance Document · Center for Drug Evaluation and Research
• Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for IndustryGuidance Document · Office of the Commissioner
• eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable MonographsGuidance Document · Center for Drug Evaluation and Research
• Medical Gases — Current Good Manufacturing Practice: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• QE3 Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable MonographsGuidance Document · Center for Drug Evaluation and Research
• Q3E Guideline for Extractables and LeachablesGuidance Document · Center for Drug Evaluation and Research
• Cross-Center Master Files: Where to Submit: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for IndustryGuidance Document · Office of the Commissioner
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Menstrual Products – Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Expanded Access to Investigational Drugs for Treatment Use: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome AssessmentsGuidance Document · Center for Drug Evaluation and Research
• Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias: Guidance for Industry Technical Specifications DocumentGuidance Document · Office of the Commissioner
• CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication: Guidance for IndustryGuidance Document · Center for Veterinary Medicine
• E20 Adaptive Designs for Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Malaria: Developing Drugs for Treatment: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Disseminated Coccidioidomycosis: Developing Drugs for Treatment: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Erosive Esophagitis: Developing Drugs for Treatment: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Erosive Esophagitis: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Disseminated Coccidioidomycosis: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending ApplicationsGuidance Document · Center for Drug Evaluation and Research
• Development of Non-Opioid Analgesics for Chronic Pain: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• E6(R3) Good Clinical Practice (GCP)Guidance Document · Center for Drug Evaluation and Research
• Classification Categories for Certain Supplements Under BsUFA IIIGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related ProductsGuidance Document · Center for Veterinary Medicine
• Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)Guidance Document · Center for Veterinary Medicine
• Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign GovernmentsGuidance Document · Center for Devices and Radiological Health
• E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research