Guidances directory

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All guidance documents2,854 total

Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Application User Fees for Combination Products: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and OlderGuidance Document · Center for Drug Evaluation and Research
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination ProductsGuidance Document · Center for Drug Evaluation and Research
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for IndustryGuidance Document · Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Office of the Commissioner,Office of Minority Health and Health Equity Office of the Commissioner,Office of Women's Health
CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review ProcessGuidance Document · Center for Veterinary Medicine
CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in DogsGuidance Document · Center for Veterinary Medicine
Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated ArticlesGuidance Document · Center for Veterinary Medicine
CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal UseGuidance Document · Center for Veterinary Medicine
Considerations in Demonstrating Interchangeability With a Reference Product: UpdateGuidance Document · Center for Drug Evaluation and Research
CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally ActingGuidance Document · Center for Veterinary Medicine
CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug ApplicationsGuidance Document · Center for Veterinary Medicine
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for IndustryGuidance Document · Office of Inspections and Investigations
Facility Readiness: Goal Date Decisions Under GDUFAGuidance Document · Center for Drug Evaluation and Research
Diabetic Foot Infections: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research SubmissionsGuidance Document · Center for Biologics Evaluation and Research
Platform Technology Designation Program for Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1)Guidance Document · Center for Veterinary Medicine
Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
REMS Logic Model: A Framework to Link Program Design With AssessmentGuidance Document · Center for Drug Evaluation and Research
CVM GFI #290 (VICH GL61) – Pharmaceutical DevelopmentGuidance Document · Center for Veterinary Medicine
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based ApproachGuidance Document · Center for Veterinary Medicine
Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical ProductsGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #120 Veterinary Feed Directive Regulation Questions and AnswersSmall Entity Compliance Guide · Center for Veterinary Medicine
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAsGuidance Document · Center for Drug Evaluation and Research
Small Entity Compliance Guide: Revocation of Uses of Partially Hydrogenated Oils in FoodsSmall Entity Compliance Guide · Human Foods Program
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical ProductsGuidance Document · Center for Biologics Evaluation and Research
Data Integrity for In Vivo Bioavailability and Bioequivalence StudiesGuidance Document · Center for Drug Evaluation and Research
Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary SupplementsGuidance Document · Human Foods Program
Draft Guidance for Industry: New Dietary Ingredient Notifications and Related IssuesGuidance Document · Human Foods Program
Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
CVM GFI #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAsGuidance Document · Center for Veterinary Medicine
Controlled Correspondence Related to Generic Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on DosingGuidance Document · Center for Drug Evaluation and Research
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug ProductsGuidance Document · Center for Drug Evaluation and Research
Early Alzheimer’s Disease: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Q14 Analytical Procedure DevelopmentGuidance Document · Center for Drug Evaluation and Research
Q2(R2) Validation of Analytical ProceduresGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary SupplementsGuidance Document · Human Foods Program
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review BoardsGuidance Document · Center for Drug Evaluation and Research
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Foods Derived from Plants Produced Using Genome EditingGuidance Document · Human Foods Program
Charging for Investigational Drugs Under an IND: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Use of Data Monitoring Committees in Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C ActGuidance Document · Center for Drug Evaluation and Research
Draft Guidance for Industry: Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPEGuidance Document · Human Foods Program
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C ActGuidance Document · Center for Drug Evaluation and Research
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell ProductsGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of DataGuidance Document · Center for Veterinary Medicine
CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary MedicineGuidance Document · Center for Veterinary Medicine
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical ProductsGuidance Document · Center for Drug Evaluation and Research
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human FoodGuidance Document · Human Foods Program
Human Gene Therapy Products Incorporating Human Genome Editing: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal ProductsGuidance Document · Center for Veterinary Medicine
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginGuidance Document · Center for Drug Evaluation and Research
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Reformulating Drug Products That Contain Carbomers Manufactured With BenzeneGuidance Document · Center for Drug Evaluation and Research
Potency Assurance for Cellular and Gene Therapy ProductsGuidance Document · Center for Biologics Evaluation and Research
Quality Considerations for Topical Ophthalmic Drug ProductsGuidance Document · Center for Drug Evaluation and Research
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Rare Diseases: Considerations for the Development of Drugs and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Digital Health Technologies for Remote Data Acquisition in Clinical InvestigationsGuidance Document · Center for Drug Evaluation and Research
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor SpeciesGuidance Document · Center for Veterinary Medicine
Master Protocols for Drug and Biological Product DevelopmentGuidance Document · Center for Drug Evaluation and Research
Data Standards for Drug and Biological Product Submissions Containing Real-World Data: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use AuthorizationGuidance Document · Center for Drug Evaluation and Research
Clinical Pharmacology Considerations for Peptide Drug ProductsGuidance Document · Center for Drug Evaluation and Research
Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Draft Guidance for Industry: Menu Labeling Supplemental Guidance (Edition 2)Guidance Document · Human Foods Program
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and AdvertisementsGuidance Document · Center for Drug Evaluation and Research
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #199 Animal Generic Drug User Fees and Fee Waivers and ReductionsGuidance Document · Center for Veterinary Medicine
Small Entity Compliance Guide: Milk and Cream Products and Yogurt Products; Final Rule to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for YogurtSmall Entity Compliance Guide · Human Foods Program
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Translation of Good Laboratory Practice Study Reports: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product ListingGuidance Document · Office of the Commissioner
Real-Time Oncology Review (RTOR) : Guidance for IndustryGuidance Document · Office of the Commissioner
Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response TheoryGuidance Document · Center for Drug Evaluation and Research
Submitting Patient-Reported Outcome Data in Cancer Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring FacilitiesGuidance Document · Center for Drug Evaluation and Research