Guidances directory

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All guidance documents2,854 total

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Obesity and Overweight: Developing Drugs and Biological Products for Weight ReductionGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)Guidance Document · Human Foods Program
Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination EventGuidance Document · Human Foods Program
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Considerations for Complying with 21 CFR 211110Guidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young ChildrenGuidance Document · Human Foods Program
Validation and Verification of Analytical Testing Methods Used for Tobacco ProductsGuidance Document · Center for Tobacco Products
Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived FoodsGuidance Document · Human Foods Program
Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic ActGuidance Document · Human Foods Program
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Advanced Manufacturing Technologies Designation ProgramGuidance Document · Center for Drug Evaluation and Research
E6(R3) Good Clinical Practice: Annex 2Guidance Document · Center for Drug Evaluation and Research
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and DevicesGuidance Document · Center for Drug Evaluation and Research
E11A Pediatric ExtrapolationGuidance Document · Center for Drug Evaluation and Research
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing DocumentGuidance Document · Office of the Commissioner
Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH): Guidance for Industry Technical Specifications DocumentGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and ProductsGuidance Document · Office of the Commissioner
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Accelerated Approval – Expedited Program for Serious ConditionsGuidance Document · Center for Drug Evaluation and Research
CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine MastitisGuidance Document · Center for Veterinary Medicine
Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant FormulaGuidance Document · Human Foods Program
Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy SubjectsGuidance Document · Center for Drug Evaluation and Research
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; AvailabilityGuidance Document · Office of the Commissioner
Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic ProductsGuidance Document · Office of the Commissioner
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review OrganizationsGuidance Document · Center for Devices and Radiological Health
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy ProductsGuidance Document · Center for Biologics Evaluation and Research
Nonclinical Safety Assessment of Oligonucleotide-Based TherapeuticsGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: FDA's Voluntary Qualified Importer ProgramGuidance Document · Human Foods Program
CPG Sec 540525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 710824)Compliance Policy Guide (CPG) · Human Foods Program
M13A Bioequivalence for Immediate-Release Solid Oral Dosage FormsGuidance Document · Center for Drug Evaluation and Research
CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed IngredientsGuidance Document · Center for Veterinary Medicine
Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial ContaminationGuidance Document · Office of the Commissioner
Drug Interaction Information in Human Prescription Drug and Biological Product LabelingGuidance Document · Center for Drug Evaluation and Research
Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for IndustryGuidance Document · Office of the Commissioner
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat MethodGuidance Document · Center for Biologics Evaluation and Research
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Guidance for IndustryGuidance Document · Office of the Commissioner
Postoperative Nausea and Vomiting: Developing Drugs for PreventionGuidance Document · Center for Drug Evaluation and Research
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFAGuidance Document · Center for Drug Evaluation and Research
Requests for Reconsideration at the Division Level Under GDUFAGuidance Document · Center for Drug Evaluation and Research
Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat FoodGuidance Document · Center for Veterinary Medicine
Temporary Policies for Compounding Certain Parenteral Drug Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Dental Cements - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)Guidance Document · Center for Veterinary Medicine
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance StudiesGuidance Document · Center for Drug Evaluation and Research
An Acceptable Circular of Information for the Use of Human Blood and Blood Components: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Small Entity Compliance Guide: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionSmall Entity Compliance Guide · Human Foods Program
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Conducting Clinical Trials With Decentralized ElementsGuidance Document · Center for Drug Evaluation and Research
CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing StrategiesGuidance Document · Center for Veterinary Medicine
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development ProgramsGuidance Document · Office of the Commissioner
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Enforcement Policy for Required Warnings for Cigarette Packages and AdvertisementsGuidance Document · Center for Tobacco Products
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)Guidance Document · Center for Tobacco Products
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for IndustrySmall Entity Compliance Guide · Center for Tobacco Products
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Control of Nitrosamine Impurities in Human Drugs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Bioresearch Monitoring Technical Conformance GuideGuidance Document · Center for Drug Evaluation and Research
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and TerminologyGuidance Document · Center for Veterinary Medicine
CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: MethodologyGuidance Document · Center for Veterinary Medicine
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Draft Guidance for Industry: Voluntary Sodium Reduction Goals (Edition 2)Guidance Document · Human Foods Program
Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases: Guidance for Industry; AvailabilityGuidance Document · Office of the Commissioner
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
M12 Drug Interaction Studies: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
M12 Drug Interaction StudiesGuidance Document · Center for Drug Evaluation and Research
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Providing Over-the-Counter Monograph Submissions in Electronic FormatGuidance Document · Center for Drug Evaluation and Research
CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)Guidance Document · Center for Veterinary Medicine
Container Closure System and Component Changes: Glass Vials and StoppersGuidance Document · Center for Drug Evaluation and Research
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Pediatric Inflammatory Bowel Disease: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research