Guidances directory

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All guidance documents2,854 total

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022Guidance Document · Center for Drug Evaluation and Research
S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #108 Registering with CVM’s Electronic Submission SystemGuidance Document · Center for Veterinary Medicine
Acute Radiation Syndrome: Developing Drugs for Prevention and TreatmentGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Transition from Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionGuidance Document · Human Foods Program
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #170 Animal Drug User Fees and Fee Waivers and ReductionsGuidance Document · Center for Veterinary Medicine
Over-the-Counter Monograph Order Requests: Format and ContentGuidance Document · Center for Drug Evaluation and Research
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-MakingGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug AdministrationGuidance Document · Human Foods Program
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments: Guidance for IndustryGuidance Document · Center for Tobacco Products
CVM GFI #281 Infectious Otitis Externa Drugs for Topical Use in DogsGuidance Document · Center for Veterinary Medicine
Tobacco Health Document Submission (Revised): Guidance for IndustryGuidance Document · Center for Tobacco Products
Identification of Medicinal Products — Implementation and UseGuidance Document · Center for Drug Evaluation and Research
Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and SponsorsGuidance Document · Office of the Commissioner
Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food LabelingGuidance Document · Human Foods Program
Clinical Trial Considerations to Support Accelerated Approval of Oncology TherapeuticsGuidance Document · Office of the Commissioner
Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide: Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
Pharmacogenomic Data SubmissionsGuidance Document · Center for Drug Evaluation and Research
Prohibition of Distributing Free Samples of Tobacco Products: Guidance for IndustryGuidance Document · Center for Tobacco Products
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops: Guidance for IndustryGuidance Document · Center for Tobacco Products
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for IndustryGuidance Document · Center for Tobacco Products
Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order: Guidance for Tobacco RetailersGuidance Document · Center for Tobacco Products
Listing of Ingredients in Tobacco Products: Guidance for IndustryGuidance Document · Center for Tobacco Products
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #106 The Use of Published Literature in Support of New Animal Drug ApprovalsGuidance Document · Center for Veterinary Medicine
Guidance for Industry: Frequently Asked Questions About Medical Foods - Third EditionGuidance Document · Human Foods Program
Development of Local Anesthetic Drug Products With Prolonged Duration of EffectGuidance Document · Center for Drug Evaluation and Research
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Labeling of Infant FormulaGuidance Document · Human Foods Program
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral PathogensGuidance Document · Center for Drug Evaluation and Research
Q13 Continuous Manufacturing of Drug Substances and Drug Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Neovascular Age-Related Macular Degeneration: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 102030, 102031, 102032, 102033); Small Entity Compliance GuideGuidance Document · Center for Devices and Radiological Health
Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Laser Products - Conformance with IEC 60825-1 Ed 3 and IEC 60601-2-22 Ed 31 (Laser Notice No 56): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray EquipmentGuidance Document · Center for Devices and Radiological Health
Draft Guidance for Industry: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient StatementsGuidance Document · Human Foods Program
Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Surveying, Leveling, and Alignment Laser Products: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Acromegaly: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug CarryoverGuidance Document · Center for Veterinary Medicine
CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health ConcernGuidance Document · Center for Veterinary Medicine
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Mpox: Development of Drugs and Biological Products; Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and AnimalsGuidance Document · Human Foods Program
Format and Content of a REMS Document Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
REMS Document Technical Conformance GuideGuidance Document · Center for Drug Evaluation and Research
M11 Clinical Electronic Structured Harmonised ProtocolGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Best Practices for Convening a GRAS PanelGuidance Document · Human Foods Program
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Homeopathic Drug Products Guidance for FDA Staff and IndustryGuidance Document · Center for Drug Evaluation and Research
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer: Guidance for IndustryGuidance Document · Office of the Commissioner
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
Clinical Investigator Administrative Actions - Disqualification: Guidance for Institutional Review Boards, Clinical Investigators, and SponsorsGuidance Document · Office of the Commissioner
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Sameness Evaluations in an ANDA — Active IngredientsGuidance Document · Center for Drug Evaluation and Research
M10 Bioanalytical Method Validation and Study Sample AnalysisGuidance Document · Center for Drug Evaluation and Research
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Cross Labeling Oncology Drugs in Combination RegimensGuidance Document · Center for Drug Evaluation and Research
Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee ProgramGuidance Document · Center for Drug Evaluation and Research
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; AvailabilityGuidance Document · Center for Drug Evaluation and Research
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAsGuidance Document · Center for Drug Evaluation and Research
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAsGuidance Document · Center for Drug Evaluation and Research
Human Gene Therapy for Neurodegenerative Diseases: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Multiple Endpoints in Clinical Trials: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based ProductsGuidance Document · Center for Veterinary Medicine
CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based ProductsGuidance Document · Center for Veterinary Medicine
Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign GovernmentGuidance Document · Human Foods Program
Small Entity Compliance Guide: Laboratory Accreditation for Analyses of Foods - What You Need to KnowSmall Entity Compliance Guide · Human Foods Program
CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated FeedsGuidance Document · Center for Veterinary Medicine
Tissue Agnostic Drug Development in Oncology: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Guidance for Industry; AvailabilityGuidance Document · Office of the Commissioner
Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; AvailabilityGuidance Document · Office of the Commissioner
ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLAGuidance Document · Center for Drug Evaluation and Research
Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Competitive Generic TherapiesGuidance Document · Center for Drug Evaluation and Research