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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
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