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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 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 2/03/2020
Clinical/ Medical Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry Final 1/24/2020
User Fees Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry Final 1/23/2020
Combination Products Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry Draft 12/18/2019
Drug Development Tools; Clinical/Medical Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff Draft 12/13/2019
Clinical/Medical Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry Draft 12/06/2019
Clinical/Medical Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry Draft 12/04/2019
Biostatistics, Clinical - Medical Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry Final 11/29/2019
Biosimilarity Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products Guidance for Industry Draft 11/25/2019
Pharmaceutical Quality/CMC Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry Draft 11/20/2019
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 2/03/2020
Clinical/ Medical Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry Final 1/24/2020
User Fees Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry Final 1/23/2020
Combination Products Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry Draft 12/18/2019
Drug Development Tools; Clinical/Medical Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff Draft 12/13/2019
Clinical/Medical Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry Draft 12/06/2019
Clinical/Medical Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry Draft 12/04/2019
Biostatistics, Clinical - Medical Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry Final 11/29/2019
Biosimilarity Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products Guidance for Industry Draft 11/25/2019
Pharmaceutical Quality/CMC Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry Draft 8/13/2019
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
Compounding Section 503A Bulks List Final Rule Questions and Answers Guidance for Industry (Small Entity Compliance Guide) Final 5/24/2019
Biosimilars Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry Draft 5/21/2019
Biosimilars Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry Final 5/10/2019
Biosimilars Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry Final 5/10/2019
Generics Determining Whether to Submit an ANDA or a 505(b)(2) Application  Final 5/9/2019
Clinical Pharmacology; Over the Counter Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations   Final 5/9/2019
Pharmacology/Toxicology Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations     Final 5/9/2019
Clinical/Medical Clinical Lactation Studies: Considerations for Study Design     Draft 5/8/2019
Clinical/Medical Postapproval Pregnancy Safety Studies Guidance for Industry     Draft 5/8/2019
Clinical/Medical Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics     Draft 5/8/2019
Clinical/Medical Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment     Draft 5/3/2019
Biostatistics Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes    Draft 4/24/2019
Procedural Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles Final 4/24/2019
Pharmaceutical Quality/CMC Bispecific Antibody Development Programs Draft 4/18/2019
Drug Safety REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Final 4/4/2019
Labeling Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice Final 3/27/2019
Rare Diseases Rare Diseases: Natural History Studies for Drug Development Draft 3/22/2019
Clinical / Medical Pediatric HIV Infection: Drug Development for Treatment Final 3/19/2019
Clinical / Antimicrobial Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Final 3/19/2019