| Clinical Pharmacology |
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry |
Draft |
8/7/2020 |
| Procedural |
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry |
Final |
8/5/2020 |
| Procedural |
Pediatric Study Plans:Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry |
Final |
7/31/2020 |
| Clinical/ Medical |
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval Guidance for Industry |
Final |
7/29/2020 |
| Labeling |
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry |
Draft |
7/29/2020 |
| Pharmaceutical Quality/CGMP |
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Guidance for Industry |
Final |
7/29/2020 |
| Chemisty, Manufacturing Control (CMC) |
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry |
Draft |
7/28/2020 |
| Pharmaceutical Quality/CMC |
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry |
Draft |
7/21/2020 |
| Clinical / Medical |
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections |
Final |
7/10/2020 |
| Clinical / Medical |
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies |
Final |
7/10/2020 |
| Clinical / Medical |
Cancer Clinical Trial Eligibility Criteria: Brain Metastases |
Final |
7/10/2020 |
| Clinical / Medical |
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients |
Final |
7/10/2020 |
| Clinical / Medical |
Development of Anti-Infective Drug Products for the Pediatric Population |
Draft |
6/29/2020 |
| Drug Safety |
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry |
Final |
6/29/2020 |
| Clinical / Antimicrobial |
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment |
Final |
6/24/2020 |
| Clinical / Antimicrobial |
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment |
Final |
6/24/2020 |
| COVID-19 |
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry |
Final |
6/19/2020 |
| COVID-19 |
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
6/17/2020 |
| Procedural |
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input |
Final |
6/16/2020 |
| Clincal / Medical |
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
6/2/2020 |
| Generics |
Orange Book Questions and Answers Guidance for Industry |
Draft |
5/29/2020 |
| ICH -Quality |
Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents |
Draft |
5/26/2020 |
| |
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products |
Final |
5/11/2020 |
| Clinical Medical |
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention |
Final |
5/11/2020 |
| Clinical / Antimicrobial |
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease Guidance for Industry |
Final |
5/7/2020 |
| Compounding, Clinical Medical |
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/30/2020 |
| Compounding |
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/22/2020 |
| Compounding, Pharmaceutical Quality |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/20/2020 |
| Compounding |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency |
Final |
4/16/2020 |
| Clinical / Medical |
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate |
Final |
4/13/2020 |
| Clinical / Medical |
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/10/2020 |
| Clinical / Medical |
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/09/2020 |
| User Fees |
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act |
Final |
4/03/2020 |
| Procedural |
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
Final |
3/27/2020 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP)/Over-the-Counter (OTC) |
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry |
Final |
3/24/2020 |
| Clinical / Medical |
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
Final |
3/22/2020 |
| Clinical / Medical |
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) |
Final |
3/19/2020 |
| Drug Safety |
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic |
Final |
3/19/2020 |
| Clinical / Medical |
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic |
Final |
3/18/2020 |
| Compounding |
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency |
Final |
3/14/2020 |
| Drug Safety |
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry |
Draft |
3/17/2020 |
| Genetics |
Competitive Generic Therapies Guidance for Industry |
Final |
3/13/2020 |
| Rare Diseases |
Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry |
Final |
3/13/2020 |
| ICH - Quality |
Q3D(R1) Elemental Impurities Guidance for Industry |
Final |
3/10/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Draft |
3/10/2020 |
| Clinical / Medical |
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control |
Draft |
3/9/2020 |
| Clinical / Medical |
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry |
Draft |
3/6/2020 |
| Pharmacology / Toxicology |
Safety Testing of Drug Metabolites Guidance for Industry |
Final, Revision 2 |
3/5/2020 |
| Procedural |
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers |
Final |
3/4/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications Revision 7 |
Final |
2/21/2020 |
| Pharm / Tox |
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry |
Revised Draft |
2/19/2020 |
| Biosimilarity |
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry |
Draft |
2/06/2020 |
| Clinical / Medical |
Mucopolysaccharidosis Type III (Sanfilippo Syndrome):Developing Drugs for Treatment Guidance for Industry |
Draft |
2/04/2020 |
| Advertising |
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry |
Draft |
2/3/2020 |
| Clinical / Antimicrobial |
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease Guidance for Industry |
Final |
5/7/2020 |
| Compounding, Clinical Medical |
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/30/2020 |
| Compounding |
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/22/2020 |
| Compounding, Pharmaceutical Quality |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/20/2020 |
| Compounding |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency |
Final |
4/16/2020 |
| Clinical / Medical |
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate |
Final |
4/13/2020 |
| Clinical / Medical |
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/10/2020 |
| Clinical / Medical |
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/09/2020 |
| User Fees |
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act |
Final |
4/03/2020 |
| Procedural |
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
Final |
3/27/2020 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP)/Over-the-Counter (OTC) |
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry |
Final |
3/24/2020 |
| Clinical / Medical |
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
Final |
3/22/2020 |
| Clinical / Medical |
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) |
Final |
3/19/2020 |
| Drug Safety |
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic |
Final |
3/19/2020 |
| Clinical / Medical |
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic |
Final |
3/18/2020 |
| Compounding |
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency |
Final |
3/14/2020 |
| Drug Safety |
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry |
Draft |
3/17/2020 |
| Genetics |
Competitive Generic Therapies Guidance for Industry |
Final |
3/13/2020 |
| Rare Diseases |
Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry |
Final |
3/13/2020 |
| ICH - Quality |
Q3D(R1) Elemental Impurities Guidance for Industry |
Final |
3/10/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Draft |
3/10/2020 |
| Clinical / Medical |
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control |
Draft |
3/9/2020 |
| Clinical / Medical |
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry |
Draft |
3/6/2020 |
| Pharmacology / Toxicology |
Safety Testing of Drug Metabolites Guidance for Industry |
Final, Revision 2 |
3/5/2020 |
| Procedural |
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers |
Final |
3/4/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications Revision 7 |
Final |
2/21/2020 |
| Pharm / Tox |
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry |
Revised Draft |
2/19/2020 |
| Biosimilarity |
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry |
Draft |
2/06/2020 |
| Clinical / Medical |
Mucopolysaccharidosis Type III (Sanfilippo Syndrome):Developing Drugs for Treatment Guidance for Industry |
Draft |
2/04/2020 |
| Advertising |
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry |
Draft |
2/3/2020 |
| Pharmaceutical Quality/CMC |
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry |
Draft |
11/1/2019 |
| Clinical / Medical |
Fabry Disease: Developing Drugs for Treatment Guidance for Industry |
Draft |
8/7/2019 |
| Pharmacology / toxicology |
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry |
Final |
8/1/2019 |
| Pharmacology / toxicology |
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers |
Draft |
7/31/2019 |
| International Council for Harmonisation - Efficacy |
E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES |
Draft |
7/31/2019 |
| Clinical / Antimicrobial |
Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry |
Final |
7/31/2019 |
| Clinical / Antimicrobial |
Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry |
Final |
7/31/2019 |
| Clinical / Antimicrobial |
Vulvovaginal Candidiasis: Developing Drugs for Treatment Guidance for Industry |
Final |
7/31/2019 |
| Clinical / Pharmacology |
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry |
Draft |
7/31/2019 |
| Clinical / Medical |
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry |
Final |
7/26/2019 |
| Clinical / Medical; Electronic Submissions |
Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document |
Final |
7/18/2019 |
| Clinical / Medical |
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry |
Draft Guidance |
7/17/2019 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry |
Draft Revision 7 |
7/16/2019 |
| Clinical/Medical |
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry |
Draft |
7/11/2019 |
| Clinical Pharmacology |
Population Pharmacokinetics Guidance for Industry |
Draft |
7/11/2019 |
| Pharmaceutical Quality/CMC |
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry |
Draft |
7/10/2019 |
| Pharmaceutical Quality/CMC |
Using the Inactive Ingredient Database Guidance for Industry |
Draft |
7/10/2019 |
| Drug Safety |
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry |
Final |
7/09/2019 |
| Compounding |
Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry |
Final |
7/05/2019 |
| Labeling |
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format Guidance for Industry |
Draft |
7/01/2019 |
| Labeling |
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry |
Draft |
7/01/2019 |
| Clinical / Medical |
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations Guidance for Industry |
Final |
6/28/2019 |
| Clinical / Medical |
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry |
Draft |
6/27/2019 |
| International Council on Harmonisation - Multidisciplinary |
M10 Bioanalytical Method Validation Guidance for Industry |
Draft |
6/26/2019 |
| International Council on Harmonisation - Efficacy |
E19 Optimisation of Safety Data Collection Guidance for Industry |
Draft |
6/26/2019 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF - 252KB) |
Final Guidance |
6/21/2019 |
| Clinical/Medical |
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry |
Draft |
6/20/2019 |
| Generics |
ANDA Submissions — Content and Format Guidance for Industry |
Final, Rev 1 |
6/12/2019 |
| Clinical/Medical |
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry |
Draft |
6/06/2019 |
| Clinical/Medical |
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry |
Draft |
6/06/2019 |
