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  1. Guidances (Drugs)

Newly Added Guidance Documents

Below is a sortable list of the most recently added Guidance Documents.

You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

Newly Added Guidance Documents

Topic Guidance Status Date
Clinical Pharmacology Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry Draft 11/30/2020
Generics Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry Final 11/24/2020
Clinical /Medical Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff Final 11/24/2020
Clinical Pharmacology Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry Draft 11/20/2020
Clinical/ Medical Cross Labeling Oncology Drugs in Combination Drug Regimens Guidance for Industry Draft 11/19/2020
Biosimilarity Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act Guidance for Industry Draft 11/19/2020
User Feed Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry Final 11/09/2020
Clinical / Medical Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry Final 11/09/2020
Pharm/tox Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry Final 10/28/2020
Generics Referencing Approved Drug Products in ANDA Submissions Guidance for Industry Final 10/27/2020
Procedural Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies Guidance for Industry Final 10/22/2020
Drug Safety Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry Draft 10/20/2020
Clinical/Medical Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry Final 10/01/2020
Phamaceutical Quality/CMC The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry Draft 9/30/2020
ICH-Safety /ICH-Efficacy E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Guidance for Industry Draft 9/29/2020
Generics Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry Draft 9/28/2020
Generics ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs Final 9/28/2020
ICH-Multidisciplinary M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers Draft 9/28/2020
Labeling Geriatric Information in Human Prescription Drug and Biological Product Labeling Draft 9/15/2020
Clinical/Medical Eosinophilic Esophagitis: Developing Drugs for Treatment Final 9/15/2020
COVID-19 Clinical/Medical Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Final 9/14/2020
COVID-19 Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency Final 9/10/2020
Pharmaceutical Quality / CGMP Control of Nitrosamine Impurities in Human Drugs Guidance for Industry Final 9/01/2020
COVID-19 Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry Final 8/19/2020
Procedural, Generics Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Guidance for Industry Final 8/18/2020
Procedural Marketing Status Notifications Under Section 506I Guidance for Industry Final 8/10/2020
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

 

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