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

Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.

CategoryTitleTypeDate
Generics /User Fees ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 833KB) Final Guidance 09/24/18
Procedural Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications (PDF - 98KB) Revised Draft Guidance 09/24/18
Procedural Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF - 319KB) Final Guidance 09/19/18
Procedural Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry (PDF - 254KB) Final guidance 09/19/18
Labeling Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers (PDF - 363KB) Draft Guidance 09/19/18
Pharmaceutical Quality/CMC. Postapproval Changes to Drug Substances Guidance for Industry (PDF - 393KB) Draft guidance 09/10/18
Clinical/Medical Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry (PDF - 120KB) Final Guidance 09/05/18
Clinical/Medical Nonallergic Rhinitis: Developing Drug Products for Treatment (PDF - 75KB) Final Guidance 09/05/18
Clinical Pharmacology Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF - 87KB) Final Guidance 09/04/18
Clinical /Medical Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development Guidance for Industry (PDF - 61KB) Draft guidance 08/23/18
Clinical / Medical Osteoarthritis: Structural Endpoints for the Development of Drugs (PDF - 60KB) Draft Guidance 08/22/18
Pharmaceutical Quality/CMC Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 169KB) Final Guidance 08/20/18
Pharmacology/Toxicology Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations (PDF - 83KB) Final Guidance 08/20/18
Procedural Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry (PDF - 145KB) Draft guidance 08/10/18
Biopharmaceuticals Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry (PDF - 103KB) Final Guidance 08/08/18
Pharmaceutical Quality/CMC Elemental Impurities in Drug Products Guidance for Industry (PDF - 92KB) Final Guidance 08/07/18
Clinical / Medical Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry (PDF - 67KB) Draft Guidance 08/06/18
Pharmacology / Toxicology Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry (PDF - 115KB) Draft guidance 08/03/18
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 (PDF - 111KB) Draft guidance 07/26/18
Pharmaceutical Quality/CMC Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments (PDF - 410KB) Draft Guidance 07/24/18
Clinical/Medical Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry (PDF - 84KB) Draft Guidance 07/23/18
International Council for Harmonisation - Efficacy E17 General Principles for Planning and Design of Multi-Regional Clinical Trials (PDF - 404KB) Final Guidance 07/18/18
Procedural / RWD/RWE Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry (PDF - 327KB) Final Guidance 07/18/18
Labeling Labeling for Biosimilar Products Guidance for Industry (PDF - 285KB) Final Guidance 07/18/18
Pharmaceutical Quality/Manufacturing Standards (CGMP). and Pharmaceutical Quality/CMC. Field Alert Report Submission: Questions and Answers Guidance for Industry (PDF - 123KB) Draft Guidance 07/18/18
Over-the-Counter Innovative Approaches for Nonprescription Drug Products (PDF - 247KB) Draft Guidance 07/17/18
Clinical / Medical Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry (PDF - 57KB) Draft Guidance 07/13/18
International Council on Harmonisation - Quality Q3D(R1) ELEMENTAL IMPURITIES (PDF - 177KB) Draft Guidance 07/13/18
Clinical / Antimicrobial Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF - 120KB) Draft Guidance 07/10/18
Labeling Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (PDF - 481KB) Draft Guidance 07/06/18
Generics/User Fees ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA (PDF - 219KB) Final Guidance 07/03/18
Pharmacology / Toxicology Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry (PDF - 263KB) Draft Guidance 06/28/18
User Fees Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (PDF - 447KB) Final Guidance 06/28/18
Clinical / Medical Major Depressive Disorder: Developing Drugs for Treatment (PDF - 291KB) Draft Guidance 06/20/18
User Fees Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry (PDF - 632KB) Draft Guidance 06/20/18
Clinical / Medical Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry (PDF - 132KB) Draft Guidance 06/15/18
International Council for Harmonisation - Safety S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers (PDF - 536KB) Final Guidance 06/15/18
Clinical /Antimicrobial Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis (PDF - 187KB) Draft Guidance 06/13/18
Procedural Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry (PDF - 128KB) Draft Guidance 06/12/18
Procedural Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (PDF - 545KB) Draft Guidance 06/12/18
Procedural Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF - 458KB) Final Guidance 06/12/18
Procedural Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff (PDF - 524KB) Final Guidance 06/12/18
User Fees Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief (PDF - 332KB) Draft Guidance 06/06/18
Biosmiliars and Procedural Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry (PDF - 184KB) Draft Guidance 06/04/18
Clinical / Medical Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials (PDF - 164KB) Draft Guidance 06/01/18
Clinical / Antimicrobial Complicated Urinary Tract Infections: Developing Drugs for Treatment (PDF - 381KB) Final Guidance 06/01/18
Drug Safety Development of a Shared System REMS Guidance for Industry (PDF - 99KB) Draft Guidance 05/31/18
Drug Safety Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry (PDF - 91KB) Draft Guidance 05/31/18
International Council for Harmonisation-Quality Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry (PDF - 451KB) Draft Guidance 05/30/18
International Council for Harmonisation-Quality Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex (PDF - 223KB) Draft Guidance 05/30/18
Clinical/Medical Assessment of Pressor Effects of Drugs Guidance for Industry (PDF - 106KB) Draft Guidance 05/30/18
Clinical / Antimicrobial Complicated Intra-Abdominal Infections: Developing Drugs for Treatment (PDF - 130KB) Final Guidance 05/29/18
Clinical / Antimicrobial; Animal Rule Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industr (PDF - 116KB) Final Guidance 05/23/18
Clinical Pharmacology / Over-the-Counter Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations (PDF - 139KB) Draft Guidance 05/22/18
Compliance Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application (PDF - 163KB) Final Guidance 05/22/18
Biopharmaceutics Bioanalytical Method Validation Guidance for Industry (PDF - 386KB) Final Guidance 05/21/18
Clinical / Medical Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment (PDF - 85KB) Final Guidance 05/21/18
Clinical / Medical Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry (PDF - 66KB) Final Guidance 05/18/18
Clinical / Antimicrobial Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease (PDF - 457KB) Draft Guidance 05/18/18
Clinical / Medical Pediatric HIV Infection: Drug Development for Treatment (PDF - 64KB) Draft Guidance 05/11/18
Compounding Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 87KB) Final Guidance 05/10/18
Clinical Antimicrobial Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry (PDF - 124KB) Draft Guidance 05/09/18
International Council for Harmonisation - Safety S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling (PDF - 149KB) Final Guidance 05/09/18
Procedural Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 117KB) Draft Guidance 05/08/18
User Fees Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry (PDF - 145KB) Final Guidance 05/02/18

Page Last Updated: 09/24/2018
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