Guidances directory

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All guidance documents2,854 total

Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Small Entity Compliance Guide: Mitigation Strategies to Protect Food Against Intentional AdulterationSmall Entity Compliance Guide · Human Foods Program
CVM GFI #232 (VICH GL54) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)Guidance Document · Center for Veterinary Medicine
CVM GFI #237 Oncology Drugs for Companion AnimalsGuidance Document · Center for Veterinary Medicine
Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese ProductsGuidance Document · Human Foods Program
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial DiseasesGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food RuleGuidance Document · Human Foods Program
Consumer Antiseptic Wash Final Rule Questions and Answers: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual SolventsGuidance Document · Center for Drug Evaluation and Research Center for Biologics Evaluation and Research
PDEs for Triethylamine and for MethylisobutylketoneGuidance Document · Center for Drug Evaluation and Research
M4E(R2): The CTD – EfficacyGuidance Document · Center for Drug Evaluation and Research
Q3C Maintenance ProceduresGuidance Document · Center for Drug Evaluation and Research
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs RegulationGuidance Document · Human Foods Program
Assessment of Abuse Potential of DrugsGuidance Document · Center for Drug Evaluation and Research
Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat FoodsGuidance Document · Human Foods Program
2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other StakeholdersGuidance Document · Office of the Commissioner
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry 180-Day Exclusivity: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Nonproprietary Naming of Biological Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA StaffGuidance Document · Center for Drug Evaluation and Research
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin ReactionsGuidance Document · Center for Drug Evaluation and Research
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act”Guidance Document · Center for Drug Evaluation and Research
Botanical Drug Development: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference ProductGuidance Document · Center for Drug Evaluation and Research
ANDA Submissions -- Refuse-to-Receive Standards Rev2Guidance Document · Center for Drug Evaluation and Research
Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Draft Guidance for Industry: Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum LevelGuidance Document · Office of the Commissioner
CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug ApplicationsGuidance Document · Center for Veterinary Medicine
Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions (*Revised): Guidance for IndustryGuidance Document · Center for Tobacco Products
CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence StudyGuidance Document · Center for Veterinary Medicine
Gifts to FDA: Evaluation and Acceptance: Guidance for the Public and FDA StaffGuidance Document · Office of the Commissioner
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and SponsorsGuidance Document · Center for Drug Evaluation and Research
Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
CPG Sec 615115 Extralabel Use of Medicated Feeds for Minor SpeciesCompliance Policy Guide (CPG) · Center for Veterinary Medicine
Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)Guidance Document · Center for Drug Evaluation and Research
Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Submission of Quality Metrics Data Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Nonprescription Sunscreen Drug Products – Format and Content of Data SubmissionsGuidance Document · Center for Drug Evaluation and Research
Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Safety Testing of Drug MetabolitesGuidance Document · Center for Drug Evaluation and Research
Nonprescription Sunscreen Drug Products – Safety and Effectiveness DataGuidance Document · Center for Drug Evaluation and Research
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Non-Inferiority Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507)Small Entity Compliance Guide · Center for Veterinary Medicine
Guidance for Industry: Submitting Forms for Food Canning Establishment Registration and Food Process Filing to FDA in Electronic or Paper FormatGuidance Document · Human Foods Program
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Small Entity Compliance Guide: What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human FoodSmall Entity Compliance Guide · Human Foods Program
Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMAGuidance Document · Human Foods Program
Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CPG Sec 101100 FDA Considerations for Recommending Charges for Causing the Introduction of Violative Products into Interstate CommerceCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Sunscreen Innovation Act: Section 586C(c) Advisory Committee ProcessGuidance Document · Center for Drug Evaluation and Research
Tropical Disease Priority Review VouchersGuidance Document · Center for Drug Evaluation and Research
Tropical Disease Priority Review VouchersGuidance Document · Center for Drug Evaluation and Research
Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal FoodGuidance Document · Human Foods Program
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food ProductsGuidance Document · Human Foods Program
Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #233 Veterinary Feed Directive Common Format Questions and AnswersGuidance Document · Center for Veterinary Medicine
Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Recommendations for Microbial Vectors Used for Gene Therapy: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and LabelingGuidance Document · Human Foods Program
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CPG Sec 150200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)Guidance Document · Human Foods Program
“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and FDA StaffGuidance Document · Center for Tobacco Products
CVM GFI #239 Human Food By-Products For Use As Animal FoodGuidance Document · Center for Veterinary Medicine
Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and FacilitiesGuidance Document · Human Foods Program
Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling: Guidance for Industry, Food and Drug Administration Staff, and Other StakeholdersGuidance Document · Center for Devices and Radiological Health
Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending MachinesGuidance Document · Human Foods Program
Small Entity Compliance Guide: Calorie Labeling of Articles of Food in Vending MachinesSmall Entity Compliance Guide · Human Foods Program
Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)Guidance Document · Center for Drug Evaluation and Research