Guidances directory

Complete index, 2,854 entries. Search and filter guidances →

All guidance documents2,854 total

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
Redbook 2000: VII Glossary, Acronyms and DefinitionsGuidance Document · Human Foods Program
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
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: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First EditionGuidance Document · Human Foods Program
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
Redbook 2000: IV.B.2 Guidelines for Reporting the Results of Toxicity StudiesGuidance Document · Human Foods Program
Redbook 2000: IV.C.5.b. One-Year Toxicity Studies with Non-RodentsGuidance Document · Human Foods Program
Redbook 2000: IV.C.4.b. Subchronic Toxicity Studies with Non-RodentsGuidance Document · Human Foods Program
Redbook 2000: IV.C.4.a. Subchronic Toxicity Studies with RodentsGuidance Document · Human Foods Program
Redbook 2000: IV.C.3.b. Short-Term Toxicity Studies with Non-RodentsGuidance Document · Human Foods Program
Redbook 2000: IV.C.3.a. Short-Term Toxicity Studies with RodentsGuidance Document · Human Foods Program
Redbook 2000: IV.C.1.b. In vitro Mammalian Chromosomal Aberration TestGuidance Document · Human Foods Program
Redbook 2000: IV.B.1. General Guidelines for Designing and Conducting Toxicity StudiesGuidance Document · Human Foods Program
Redbook 2000: IV. A. Introduction to Guidelines for Toxicity StudiesGuidance Document · Human Foods Program
Small Entity Compliance Guide: Label Warning Statements for Iron-Containing Supplements and DrugsSmall Entity Compliance Guide · Human Foods Program
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
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