Guidances directory

All guidance documents2,828 total

• 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• Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research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
• Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3): Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)”Guidance 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• Withdrawn CDER Product Specific GuidancesGuidance Document · Center for Drug Evaluation and Research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
• Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug ApplicationGuidance Document · Center for Drug 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
• Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Requesting FDA Feedback on Combination Products : Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
• Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Compliance Policy Guide CPG Sec 110650 Weekly Entry Filing Guidance for Industry and FDA StaffCompliance Policy Guide (CPG) · Office of the Commissioner
• CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug ProductsGuidance Document · Center for Veterinary Medicine
• Qualification Process for Drug Development Tools Guidance for Industry and FDA StaffGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and AnswersGuidance Document · Center for Veterinary Medicine
• Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Guidance for Industry and FDA StaffGuidance Document · Office of Inspections and Investigations
• Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration StaffGuidance Document · Office of the Commissioner
• CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis ProgramsGuidance Document · Center for Veterinary Medicine
• Regulatory Considerations for Microneedling Products: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Draft Guidance for Industry: Voluntary Disclosure of Sesame as an AllergenGuidance Document · Human Foods Program
• Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Insanitary Conditions at Compounding Facilities Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System OutagesGuidance Document · Human Foods Program
• Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Referencing Approved Drug Products in ANDA Submissions Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Guidance for Industry: US Agent Voluntary Identification System (VIS) for Food Facility RegistrationGuidance Document · Human Foods Program
• Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts LabelsGuidance Document · Human Foods Program
• Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for IndustryGuidance Document · Office of the Commissioner
• The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Breast Implants - Certain Labeling Recommendations to Improve Patient Communication: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health