Guidances directory

All guidance documents2,828 total

• Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Recognition and Withdrawal of Voluntary Consensus Standards: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #191 Changes to Approved NADAs - New NADAs vs Category II Supplemental NADAsGuidance Document · Center for Veterinary Medicine
• Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Civil Money Penalties Relating to the ClinicalTrialsgov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA StaffGuidance Document · Office of the Commissioner
• Male Breast Cancer: Developing Drugs for Treatment: Guidance for IndustryGuidance Document · Office of the Commissioner
• Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for InfantsGuidance Document · Human Foods Program
• CPG Sec 280110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping ReagentsCompliance Policy Guide (CPG) · Center for Biologics Evaluation and Research
• CPG Sec 280100 - Stability Requirements - Licensed In Vitro Diagnostic ProductsCompliance Policy Guide (CPG) · Center for Biologics Evaluation and Research
• Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study PlansGuidance Document · Center for Drug Evaluation and Research
• Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug AdministrationGuidance Document · Center for Devices and Radiological Health
• Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated ApprovalGuidance Document · Center for Drug Evaluation and Research
• Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Biologics Evaluation and Research
• Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Clinical Investigations for Prostate Tissue Ablation Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CPG Sec 540750 - Use of The Seafood List to Determine Acceptable Seafood NamesCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent MalignanciesGuidance Document · Center for Drug Evaluation and Research
• Cancer Clinical Trial Eligibility Criteria: Brain MetastasesGuidance Document · Center for Drug Evaluation and Research
• Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric PatientsGuidance Document · Center for Drug Evaluation and Research
• Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus InfectionsGuidance Document · Center for Drug Evaluation and Research
• Review and Update of Device Establishment Inspection Processes and Standards: Guidance for IndustryGuidance Document · Office of Inspections and Investigations
• CDER CDRH Combo Product Compliance ProgramProgram · Center for Biologics Evaluation and Research
• CVM GFI #240 Proprietary Names for New Animal DrugsGuidance Document · Center for Veterinary Medicine
• Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a PandemicGuidance Document · Center for Drug Evaluation and Research
• Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for IndustryGuidance Document · Center for Tobacco Products
• Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
• CVM GFI #259 (VICH GL58) Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IVGuidance Document · Center for Veterinary Medicine
• Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products: Guidance for IndustryGuidance Document · Office of the Commissioner
• Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C ActGuidance Document · Center for Drug Evaluation and Research
• Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CPG Section 110800 Post Detention Sampling Guidance for IndustryCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Product Recalls, Including Removals and Corrections: Guidance for IndustryGuidance Document · Office of Inspections and Investigations
• CVM GFI #264 Standardized Medicated Feed Assay LimitsGuidance Document · Center for Veterinary Medicine
• Recommendations for Dual 510(k) and CLIA Waiver by Application Studies: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Specifications for Preparing and Submitting Electronic ICSRs and ICSR AttachmentsGuidance Document · Center for Drug Evaluation and Research
• Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional AdulterationGuidance Document · Human Foods Program
• Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for IndustyGuidance Document · Center for Drug Evaluation and Research
• Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts LabelsSmall Entity Compliance Guide · Human Foods Program
• Human Gene Therapy for Rare Diseases: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Human Gene Therapy for Retinal Disorders: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Human Gene Therapy for Hemophilia: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous TopicsGuidance Document · Human Foods Program
• Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry; Technical Specifications DocumentGuidance Document · Center for Biologics Evaluation and Research
• Considerations for the Development of Dried Plasma Products Intended for Transfusion: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and MineralsGuidance Document · Human Foods Program
• Chapter 2 - BiologicsCompliance Policy Guide (CPG) · Center for Biologics Evaluation and Research
• Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Adaptive Design Clinical Trials for Drugs and Biologics Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 230150 Blood Donor Classification Statement, Paid or Volunteer DonorCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products: Guidance for IndustryCompliance Policy Guide (CPG) · Center for Tobacco Products
• Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin ProductsGuidance Document · Center for Drug Evaluation and Research
• Transdermal and Topical Delivery Systems - Product Development and Quality ConsiderationsGuidance Document · Center for Drug Evaluation and Research
• Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Drug Master Files Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Safety and Performance Based Pathway: Guidance for Industry and Food and Drug AdministrationGuidance Document · Center for Devices and Radiological Health