Guidances directory

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All guidance documents2,854 total

DSCSA Implementation: Product Tracing Requirements — Compliance PolicyGuidance Document · Center for Drug Evaluation and Research
Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
CPG Sec 540275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coliCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics ProvidersGuidance Document · Center for Drug Evaluation and Research
Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
SUPAC: Manufacturing Equipment AddendumGuidance Document · Center for Drug Evaluation and Research
Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final GuidanceGuidance Document · Center for Biologics Evaluation and Research
CPG Sec 540700 Labeling of Processed and Blended Seafood Products Made Primarily with Fish ProteinCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance Document · Center for Drug Evaluation and Research
Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Vaginal Microbicides:Development for the Prevention of HIV Infection PDFGuidance Document · Center for Drug Evaluation and Research
Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
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
Upper Facial Lines: Developing Botulinum Toxin Drug ProductsGuidance Document · Center for Drug Evaluation and Research
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
Drug Master Files: GuidelinesGuidance Document · Center for Drug Evaluation and Research
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
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
FDA's Strategy on Antimicrobial Resistance - Questions and AnswersGuidance Document · Center for Veterinary Medicine
CPG Sec. 460.200 Pharmacy Compounding (Withdrawn December 4, 2013)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
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