Guidances directory

All guidance documents2,320 total

• Specification of the Unique Facility Identifier (UFI) System for Drug EstablishmentGuidance Document · Center for Drug Evaluation and Research
• New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of TermsGuidance Document · Center for Veterinary Medicine
• New/Revised/Withdrawn Guidances 2014Guidance Document · Center for Drug Evaluation and Research
• CVM GFI #224 (Supplement to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Guidance GL52Guidance Document · Center for Veterinary Medicine
• Custom Device Exemption: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Unique Device Identifier System: Frequently Asked Questions, Vol 1 : Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Immunogenicity Assessment for Therapeutic Protein ProductsGuidance Document · Center for Drug Evaluation and Research
• Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration StaffSmall Entity Compliance Guide · Center for Devices and Radiological Health
• In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS ActGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #201 SECG for The Index of Legally Marketed Unapproved New Animal Drugs for Minor SpeciesSmall Entity Compliance Guide · Center for Veterinary Medicine
• CVM GFI #200 SECG for Designation of New Animal Drugs for Minor Uses or Minor SpeciesSmall Entity Compliance Guide · Center for Veterinary Medicine
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Reporting Drug Sample Information Under Section 6004 of the Affordable Care ActGuidance Document · Center for Drug Evaluation and Research
• Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or PreventionGuidance Document · Center for Drug Evaluation and Research
• Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act GuidanceGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color AdditivesGuidance Document · Human Foods Program
• Small Entity Compliance Guide: Gluten-Free Labeling of FoodsSmall Entity Compliance Guide · Human Foods Program
• Guidance for Industry: Safety of Nanomaterials in Cosmetic ProductsGuidance Document · Office of the Commissioner
• Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology: Guidance for IndustryGuidance Document · Office of the Commissioner
• Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical DevicesGuidance Document · Center for Drug Evaluation and Research
• Q4B Annex 6: Uniformity of Dosage Units General ChapterGuidance Document · Center for Drug Evaluation and Research
• Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended PracticesGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 10696(i) for "Eligible" Infant FormulasGuidance Document · Human Foods Program
• CPG Sec 100250 Food Facility Registration (Human and Animal Food)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
• Expedited Programs for Serious Conditions | Drugs and BiologicsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVMGuidance Document · Center for Veterinary Medicine
• Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and SponsorsGuidance Document · Office of the Commissioner
• ANDAs: Stability Testing of Drug Substances and Products, Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability DataGuidance Document · Center for Veterinary Medicine
• Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Small Entity Compliance Guide: What You Need to Know About Establishment and Maintenance of RecordsSmall Entity Compliance Guide · Human Foods Program
• Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic ActGuidance Document · Human Foods Program
• CPG Sec 550050 Canned Ackee, Frozen Ackee, and Other Ackee Products- Hypoglycin A ToxinCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug RegulationsGuidance Document · Center for Biologics Evaluation and Research
• The Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v Windsor: Questions and Answers: Guidance for Industry, Consumers, and FDA StaffGuidance Document · Office of the Commissioner
• Medical Device Tracking : Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General ConsiderationsGuidance Document · Center for Drug Evaluation and Research
• Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for TreatmentGuidance Document · Center for Drug Evaluation and Research
• CMC Postapproval Manufacturing Changes To Be Documented in Annual ReportsGuidance Document · Center for Drug Evaluation and Research
• IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry and FDA StaffGuidance Document · Center for Biologics Evaluation and Research
• BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06Guidance Document · Center for Drug Evaluation and Research
• Public Availability of Advisory Committee Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA StaffGuidance Document · Office of the Commissioner
• The Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message SpecificationGuidance Document · Center for Drug Evaluation and Research
• Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Providing Regulatory Submissions in Electronic Format--Receipt Date: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and BiologicsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary SupplementsGuidance Document · Human Foods Program
• Guidance for Industry: Distinguishing Liquid Dietary Supplements from BeveragesGuidance Document · Human Foods Program
• Attachement - Qualification Process for Drug Development Tools: Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary DiseaseGuidance Document · Center for Drug Evaluation and Research
• Community-Acquired Bacterial Pneumonia: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Dear Health Care Provider Letters: Improving Communication of Important Safety InformationGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Dear Manufacturer Letter Regarding Changes to FDA's Administration of Process Filings (Forms FDA 2541a and FDA 2541c) for Acidified Foods and Low-Acid Canned FoodsIndustry Letter · Human Foods Program
• CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209Guidance Document · Center for Veterinary Medicine
• Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 14: Bacterial Endotoxins Test General ChapterGuidance Document · Center for Drug Evaluation and Research
• Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #223 Small Entity Compliance Guide Declaring Color Additives in Animal FoodsSmall Entity Compliance Guide · Center for Veterinary Medicine
• Electronic Source Data in Clinical Investigations: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection ActGuidance Document · Human Foods Program
• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and SponsorsGuidance Document · Office of the Commissioner
• Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents: Guidance for IndustryGuidance Document · Center for Tobacco Products
• Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
• Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 690800 Compliance Policy Guide Salmonella in Food for AnimalsCompliance Policy Guide (CPG) · Center for Veterinary Medicine
• Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• ANDAs: Stability Testing of Drug Substances and ProductsGuidance Document · Center for Drug Evaluation and Research
• Codevelopment of Two or More New Investigational Drugs for Use in CombinationGuidance Document · Center for Drug Evaluation and Research
• Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Draft Guidance for Industry: Cosmetic Good Manufacturing PracticesGuidance Document · Office of the Commissioner
• Rheumatoid Arthritis: Developing Drug Products for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Annex 13: Bulk Density and Tapped Density of Powders General ChapterGuidance Document · Center for Drug Evaluation and Research
• Annex 13 Bulk Density and Tapped Density of Powders General ChapterGuidance Document · Center for Drug Evaluation and Research
• The Open Public Hearing at FDA Advisory Committee Meetings: Guidance for the Public, FDA Advisory Committee Members, and FDA StaffGuidance Document · Office of the Commissioner
• Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data SetsGuidance Document · Center for Drug Evaluation and Research
• Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Self-Selection Studies for Nonprescription Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and SponsorsGuidance Document · Office of the Commissioner
• Blood Establishment Computer System Validation in the User's Facility: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Tablet Scoring:Nomenclature, Labeling, and Data for EvaluationGuidance Document · Center for Drug Evaluation and Research