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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
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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