Guidances directory

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All guidance documents2,854 total

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Draft Guidance for Industry: Cosmetic Good Manufacturing PracticesGuidance Document · Office of the Commissioner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
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Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner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
Small Entity Compliance Guide: What You Need To Know About Administrative Detention of FoodsSmall Entity Compliance Guide · Human Foods Program
Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to GuidanceGuidance Document · Center for Drug Evaluation and Research
Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format RequirementsGuidance Document · Center for Drug Evaluation and Research
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CPG Sec. 390.225 Early Defects or Noncompliance - 21 CFR 1004.6Compliance Policy Guide (CPG) · Center for Devices and Radiological Health
Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry,and FDA StaffGuidance Document · Office of the Commissioner
E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1)Guidance Document · Center for Drug Evaluation and Research
Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for LabelingGuidance Document · Center for Drug Evaluation and Research
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
S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived PharmaceuticalsGuidance 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
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