Guidances directory

All guidance documents2,828 total

• Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for IndustryGuidance Document · Office of the Commissioner
• Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Questions and Answers on Juice HACCP Regulation (2003)Guidance Document · Human Foods Program
• Small Entity Compliance Guide: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health ClaimsSmall Entity Compliance Guide · Human Foods Program
• IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Guidance for IndustryGuidance Document · Office of the Commissioner
• Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital ReprocessorsGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary SupplementsGuidance Document · Human Foods Program
• Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same DayGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Standardized Training Curriculum for Application of HACCP Principles to Juice ProcessingGuidance Document · Human Foods Program
• Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement PolicyGuidance Document · Center for Drug Evaluation and Research
• Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and LabelingGuidance Document · Center for Drug Evaluation and Research
• INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory ApplicationsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug ResiduesGuidance Document · Center for Veterinary Medicine
• Guidance for Industry: Bulk Transport of Juice Concentrates and Certain Shelf-Stable JuicesGuidance Document · Human Foods Program
• Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARSGuidance Document · Center for Biologics Evaluation and Research
• Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999Guidance Document · Center for Drug Evaluation and Research
• Small Entity Compliance Guide: Juice HACCPSmall Entity Compliance Guide · Human Foods Program
• Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local ActionGuidance Document · Center for Drug Evaluation and Research
• User Labeling for Devices that Contain Natural Rubber (21 CFR 801437); Small Entity Compliance Guide - Guidance for IndustrySmall Entity Compliance Guide · Center for Devices and Radiological Health
• Integration of Dose-Counting Mechanisms into MDI Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Prussian Blue Drug Products — Submitting a New Drug ApplicationGuidance Document · Center for Drug Evaluation and Research
• M4: The CTD -- Safety Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical EvaluationGuidance Document · Center for Drug Evaluation and Research
• Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and ProductsGuidance Document · Center for Drug Evaluation and Research
• Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• (Potassium Iodide) KI in Radiation Emergencies-Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term "Catfish"Guidance Document · Human Foods Program
• Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)Guidance Document · Center for Devices and Radiological Health
• Food-Effect Bioavailability and Fed Bioequivalence Studies: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #80 Evaluation the Utility of Anti-Salmonella Chemical Food AdditivesGuidance Document · Center for Veterinary Medicine
• CPG Sec 555.600 Filth from Insects, Rodents, and Other Pests in FoodsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and ImportersGuidance Document · Center for Devices and Radiological Health
• Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been ReconditionedGuidance Document · Center for Veterinary Medicine Human Foods Program
• CVM GFI #82 Development of Supplemental Applications for Approved New Animal DrugsGuidance Document · Center for Veterinary Medicine
• Guidance for Small Businesses: Submission of Comments for CFSAN RulemakingGuidance Document · Human Foods Program
• Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Implementation of Section 10809 of the Farm Security and Investment Act of 2002 Regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated with IrradiationGuidance Document · Human Foods Program
• Guidance for Industry: Exemptions from the Warning Label Requirement for JuiceGuidance Document · Human Foods Program
• CVM GFI #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal DrugGuidance Document · Center for Veterinary Medicine
• Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products: Guidance for Industry and FDAGuidance Document · Center for Devices and Radiological Health
• Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Channels of Trade Policy for Commodities with Vinclozolin ResiduesGuidance Document · Human Foods Program
• Carcinogenicity Study Protocol SubmissionsGuidance Document · Center for Drug Evaluation and Research
• Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• E2BM Data Elements for Transmission Of Individual Case Safety ReportsGuidance Document · Center for Drug Evaluation and Research
• Validation of Procedures for Processing of Human Tissues Intended for Transplantation: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF)Guidance Document · Center for Biologics Evaluation and Research
• General Principles of Software Validation: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Small Entity Compliance Guide on Structure/Function ClaimsSmall Entity Compliance Guide · Human Foods Program
• Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Potassium Iodide as a Thyroid Blocking Agent in Radiation EmergenciesGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)Guidance Document · Center for Veterinary Medicine
• Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Fumonisin Levels in Human Foods and Animal FeedsGuidance Document · Center for Veterinary Medicine Human Foods Program
• Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide: Guidance for IndustrySmall Entity Compliance Guide · Center for Drug Evaluation and Research
• Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Cancer Drug and Biological Products - Clinical Data in Marketing ApplicationsGuidance Document · Center for Drug Evaluation and Research
• Redbook 2000: VI.B EpidemiologyGuidance Document · Human Foods Program
• Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001Guidance Document · Center for Drug Evaluation and Research
• Submitting Marketing Applications According to the ICH/CTD Format: General ConsiderationsGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Questions and Answers on Juice HACCP RegulationGuidance Document · Human Foods Program
• Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical IngredientsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• M4S: The CTD -- Safety AppendicesGuidance Document · Center for Drug Evaluation and Research
• M4S: The CTD -- SafetyGuidance Document · Center for Drug Evaluation and Research
• M4: The CTD -- QualityGuidance Document · Center for Drug Evaluation and Research
• Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDAGuidance Document · Center for Devices and Radiological Health
• Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices): Guidance for FDA ReviewersGuidance Document · Center for Biologics Evaluation and Research
• Premarket Notification Submissions for Blood and Plasma Warmers: Guidance for FDA ReviewersGuidance Document · Center for Biologics Evaluation and Research
• Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components: Guidance for FDA ReviewersGuidance Document · Center for Biologics Evaluation and Research
• Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New ApplicationsGuidance Document · Center for Drug Evaluation and Research
• S7A Safety Pharmacology Studies for Human PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety TrialsGuidance Document · Center for Veterinary Medicine
• CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For SubmissionGuidance Document · Center for Veterinary Medicine
• Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery ProductsGuidance Document · Human Foods Program
• Small Entity Compliance Guide: Serving Sizes Reference Amount for Baking Powder, Baking Soda, and PectinSmall Entity Compliance Guide · Human Foods Program
• Small Entity Compliance Guide: Safe Handling Statements on Labeling of Shell Eggs and the Refrigeration of Shell Eggs Held for Retail DistributionSmall Entity Compliance Guide · Human Foods Program
• Information for Keratome Manufacturers Regarding LASIK - Final Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH StaffGuidance Document · Center for Devices and Radiological Health
• Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)Guidance Document · Center for Devices and Radiological Health
• E10 Choice of Control Group and Related Issues in Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #85 (VICH GL9) Good Clinical PracticeGuidance Document · Center for Veterinary Medicine
• Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory: Guidance for Hospitals, Nursing Homes, and Other Health Care FacilitiesGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #99 (VICH GL17) Testing of New Biotechnological/Biological ProductsGuidance Document · Center for Veterinary Medicine
• Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution TestingGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products - Phase IGuidance Document · Center for Veterinary Medicine
• Monoclonal Antibodies Used as Reagents in Drug ManufacturingGuidance Document · Center for Drug Evaluation and Research
• Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH StaffGuidance Document · Center for Devices and Radiological Health
• Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Clinical Development and Labeling of Anti-Infective Drug ProductsGuidance Document · Center for Drug Evaluation and Research