Guidances directory

All guidance documents2,828 total

• Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Guidance for Industry: Food Labeling GuideGuidance Document · Human Foods Program
• Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and InvestigatorsSmall Entity Compliance Guide · Center for Drug Evaluation and Research
• Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and InvestigatorsGuidance Document · Center for Drug Evaluation and Research
• Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
• FDA Oversight of PET Drug Products -- Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Investigational New Drug Applications for Positron Emission Tomography (PET) DrugsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing AnimalsGuidance Document · Center for Veterinary Medicine
• Q11 Development and Manufacture of Drug SubstancesGuidance Document · Center for Drug Evaluation and Research
• Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
• The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Compliance Policy Guide Sec 390200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 100311Compliance Policy Guide (CPG) · Center for Devices and Radiological Health
• CPG Sec 420500 *Interference with Compendial Tests* (revised 11/14/2012)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 550050 (Draft) Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A ToxinCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus: Final Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance for Industry: Acute Bacterial Otitis Media: Developing Drugs for TreatmentGuidance Document · Center for Drug Evaluation and Research
• Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Acute Bacterial Exacerbations of Chronic Bronchitis in PatientsGuidance Document · Center for Drug Evaluation and Research
• Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion: Final Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)Guidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 490.200 Parametric Release of Parenteral Drug Products Terminally Sterilized by Moist HeatCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• Pyrogen and Endotoxins Testing: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• "Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications"Guidance Document · Center for Drug Evaluation and Research
• Irritable Bowel Syndrome -- Clinical Evaluation of Products for TreatmentGuidance Document · Center for Drug Evaluation and Research
• S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human UseGuidance Document · Center for Drug Evaluation and Research
• S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Size of Beads in Drug Products Labeled for Sprinkle Rev1: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Small Entity Compliance Guide: Establishing an Allowable Level for di (2-ethylhexyl)phthalate in Bottled WaterGuidance Document · Human Foods Program
• CVM GFI #209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing AnimalsGuidance Document · Center for Veterinary Medicine
• Media Fills for Validation of Aseptic Preparations for Positron Emission TomographyGuidance Document · Center for Drug Evaluation and Research
• Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for IndustryGuidance Document · Center for Tobacco Products
• Modified Risk Tobacco Product Applications: Draft Guidance for IndustryGuidance Document · Center for Tobacco Products
• CVM GFI #216 Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal UseGuidance Document · Center for Veterinary Medicine
• Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal FoodsGuidance Document · Human Foods Program
• FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• E7 Studies in Support of Special Populations; Geriatrics; Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and SponsorsGuidance Document · Office of the Commissioner
• Questions and Answers on Informed Consent Elements, 21 CFR § 5025(c): Guidance for Sponsors, Investigators, and Institutional Review BoardsSmall Entity Compliance Guide · Office of the Commissioner
• CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for DrugsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)Guidance Document · Human Foods Program
• Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical DevicesGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and TransportationGuidance Document · Human Foods Program
• Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic RadiopharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)Guidance Document · Center for Drug Evaluation and Research
• Q8, Q9, and Q10 Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance for Industry: Letter to Firms that Grow, Harvest, Sort, Pack, Process, or Ship Fresh CantaloupeIndustry Letter · Human Foods Program
• Guidance for Industry: Evaluating the Safety of Flood-affected Food Crops for Human ConsumptionGuidance Document · Human Foods Program
• Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
• Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization ActGuidance Document · Office of Inspections and Investigations
• Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #215 Target Animal Safety & Effectiveness Protocol Development & SubmissionGuidance Document · Center for Veterinary Medicine
• Time and Extent Applications for Nonprescription Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Applications for Premarket Review of New Tobacco Products: Draft Guidance for IndustryGuidance Document · Center for Tobacco Products
• User Fee Waivers, Reductions, and Refunds for Drug and Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• Reproductive and Developmental Toxicities -- Integrating Study Results to Assess ConcernsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #206 (VICH GL47) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory AnimalsGuidance Document · Center for Veterinary Medicine
• CVM GFI #205 (VICH GL46) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK)Guidance Document · Center for Veterinary Medicine
• Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for IndustryGuidance Document · Center for Tobacco Products
• PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011Guidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an IngredientGuidance Document · Human Foods Program
• PET Drug Applications - Content and Format for NDAs and ANDAs_2011Guidance Document · Center for Drug Evaluation and Research
• E2F Development Safety Update ReportGuidance Document · Center for Drug Evaluation and Research
• Exculpatory Language in Informed ConsentGuidance Document · Office of the Commissioner
• Residual Drug in Transdermal and Related Drug Delivery Systems: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: What You Need to Know About Prior Notice of Imported Food ShipmentsGuidance Document · Office of Inspections and Investigations Human Foods Program
• E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification SubmissionsGuidance Document · Center for Drug Evaluation and Research
• PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance GuideSmall Entity Compliance Guide · Center for Drug Evaluation and Research
• Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Q4B Annex 7 (R2): Dissolution Test General ChapterGuidance Document · Center for Drug Evaluation and Research
• Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
• Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Submission of Summary Bioequivalence Data for Abbreviated New Drug ApplicationsGuidance Document · Center for Drug Evaluation and Research
• Dosage Delivery Devices for Orally Ingested OTC Liquid Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• How to Write a Request for Designation (RFD): Guidance for IndustryGuidance Document · Office of the Commissioner
• Influenza: Developing Drugs for Treatment and/or ProphylaxisGuidance Document · Center for Drug Evaluation and Research
• Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• "Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); : Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition ProcessGuidance Document · Human Foods Program
• Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Hypertension Indication: Drug Labeling for Cardiovascular Outcome ClaimsGuidance Document · Center for Drug Evaluation and Research
• Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug ProductsCenter for Drug Evaluation and Research
• Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Letter to Firms that Grow, Harvest, Sort, Pack, or Ship Fresh CilantroIndustry Letter · Human Foods Program
• CPG Sec 335700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference SeizureCompliance Policy Guide (CPG) · Center for Devices and Radiological Health
• Sample formats for Form FDA 356h_2011Guidance Document · Center for Drug Evaluation and Research
• Process Validation: General Principles and Practices: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry:Guidance Document · Center for Biologics Evaluation and Research
• CPG Sec 527300 Microbial Contaminants & Alkaline Phosphatase ActivityCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary SupplementsSmall Entity Compliance Guide · Human Foods Program
• CPG Sec 510.800 Beverages-Serving Size LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research