Guidances directory

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All guidance documents2,854 total

Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Drug Product Tracing: The Effect of Section 585 of the FD&C ActGuidance Document · Center for Drug Evaluation and Research
Population Pharmacokinetics: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph DrugsGuidance Document · Center for Drug Evaluation and Research
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other StakeholdersGuidance Document · Center for Devices and Radiological Health
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other StakeholdersGuidance Document · Center for Devices and Radiological Health
Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
Good ANDA Submission Practices Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #159 (VICH GL36) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADIGuidance Document · Center for Veterinary Medicine
Collecting and Providing 702(b) Portions of FDA Official Samples: Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization ActGuidance Document · Human Foods Program
Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization ActGuidance Document · Human Foods Program
Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization ActGuidance Document · Human Foods Program
Inspection of Injectable Products for Visible Particulates: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Development of Anti-Infective Drug Products for the Pediatric Population : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual ReportsGuidance Document · Center for Drug Evaluation and Research
IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Tobacco Product User Fees: Responses to Frequently Asked QuestionsGuidance Document · Center for Tobacco Products
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Guidance for Industry: Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of IdentityGuidance Document · Human Foods Program
Guidance for Industry: Preparation of Food Contact Substance Notifications (Toxicology Recommendations)Guidance Document · Human Foods Program
Guidance for Industry: Preparation of Food Contact Substance Notifications (Administrative)Guidance Document · Human Foods Program
Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared FoodsGuidance Document · Human Foods Program
Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal DrugsGuidance Document · Center for Veterinary Medicine
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal DrugsGuidance Document · Center for Veterinary Medicine
CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal DrugsGuidance Document · Center for Veterinary Medicine
CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal DrugsGuidance Document · Center for Veterinary Medicine
De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Withdrawn CDER Product Specific GuidancesGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Microbiological Considerations for Antimicrobial Agents Used in Food ApplicationsGuidance Document · Human Foods Program
FDA Export Certification: Guidance for IndustryGuidance Document · Office of the Commissioner
Notifying FDA of Fatalities Related to Blood Collection or Transfusion: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical TrialsGuidance Document · Center for Drug Evaluation and Research
Development and Submission of Near Infrared Analytical ProceduresGuidance Document · Center for Drug Evaluation and Research
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)Guidance Document · Human Foods Program
CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal DrugsGuidance Document · Center for Veterinary Medicine
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases: Guidance for IndustryGuidance Document · Office of the Commissioner
Providing Regulatory Submissions in Electronic Format -- Standardized Study DataGuidance Document · Center for Drug Evaluation and Research
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment: Guidance for IndustryGuidance Document · Office of the Commissioner
CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-CounterGuidance Document · Center for Veterinary Medicine
Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CPG Sec 555400 Aflatoxins in Human FoodCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 570200 Aflatoxins in Brazil NutsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 570375 Aflatoxins in Peanuts and Peanut ProductsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 570500 Aflatoxins in Pistachio NutsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec 505B of the FD&C Act: Guidance for IndustryGuidance Document · Office of the Commissioner
Bispecific Antibody Development Programs Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)Guidance Document · Center for Drug Evaluation and Research
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
M9 Biopharmaceutics Classification System-Based BiowaiversGuidance Document · Center for Drug Evaluation and Research
S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals : International Council for Harmonisation; Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management AnnexGuidance Document · Center for Drug Evaluation and Research
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Qualified Infectious Disease Product Designation Questions and Answers: Guidance for IndustyGuidance Document · Center for Drug Evaluation and Research
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals : Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-InvestigatorsGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal PeriodGuidance Document · Human Foods Program
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Mouse Embryo Assay for Assisted Reproduction Technology DevicesGuidance Document · Center for Devices and Radiological Health
IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-InvestigatorsGuidance Document · Center for Drug Evaluation and Research
Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food LabelingGuidance Document · Human Foods Program
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Dry Eye: Developing Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) NoticesGuidance Document · Center for Veterinary Medicine
Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research