Guidances directory

All guidance documents2,320 total

• CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)Guidance Document · Center for Veterinary Medicine
• Gingivitis: Development and Evaluation of Drugs for Treatment or PreventionGuidance Document · Center for Drug Evaluation and Research
• Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
• Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• M4: The CTD -- General Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• M4: The CTD -- Efficacy Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and OmnivoresGuidance Document · Center for Veterinary Medicine
• Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and LabelingGuidance 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 and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan (PDF version)Special Controls Document · Center for Devices and Radiological Health
• The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical InvestigatorsGuidance Document · Center for Drug Evaluation and Research
• Independent Consultants for Biotechnology Clinical Trial Protocols: Guidance for IndustryGuidance Document · Office of the Commissioner
• Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug ApplicationGuidance Document · Center for Drug Evaluation and Research
• Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety AssessmentsGuidance Document · Center for Drug Evaluation and Research
• Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical StudiesGuidance Document · Center for Drug Evaluation and Research
• Developing Medical Imaging Drug and Biological Products Part 2: Clinical IndicationsGuidance Document · Center for Drug Evaluation and Research
• M4: The CTD -- Quality Questions and Answers /Location IssuesGuidance Document · Center for Drug Evaluation and Research
• Q1E Evaluation of Stability DataGuidance Document · Center for Drug Evaluation and Research
• Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System (PDF version)Special Controls Document · Center for Devices and Radiological Health
• Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Guidance for Industry and FDA Staff: Spinal System 510(k)sGuidance Document · Center for Devices and Radiological Health
• CVM GFI #144 (VICH GL27) Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial ResistanceGuidance Document · Center for Veterinary Medicine
• Changes to an Approved NDA or ANDA: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 490100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market ApprovalCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 490100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market ApprovalGuidance Document · Center for Drug Evaluation and Research
• Potassium Iodide Tablets - Shelf Life ExtensionGuidance Document · Center for Drug Evaluation and Research
• Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] SubmissionsGuidance Document · Center for Devices and Radiological Health
• IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Q1A(R2) Stability Testing of New Drug Substances and ProductsGuidance Document · Center for Drug Evaluation and Research
• E2D Postapproval Safety Data Management: Definitions and Standards for Expedited ReportingGuidance Document · Center for Drug Evaluation and Research
• 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
• 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
• 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
• 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: 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
• 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
• 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
• Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and ImportersGuidance Document · Center for Devices and Radiological Health
• CVM GFI #82 Development of Supplemental Applications for Approved New Animal DrugsGuidance Document · Center for Veterinary Medicine
• Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAsGuidance Document · Center for Drug Evaluation and Research
• 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
• 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
• 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
• 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
• Submitting Marketing Applications According to the ICH/CTD Format: General ConsiderationsGuidance Document · 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