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
Advertising Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements Guidance for Industry (PDF - 161KB) Draft Guidance 10/16/18
Clinical / Medical Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry (PDF - 174KB) Draft Guidance 10/15/18
Rare Diseases Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry (PDF - 132KB) Draft Guidance 10/15/18
Clinical Pharmacology Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry (PDF - 91KB) Final Guidance 10/15/18
Generics Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry (PDF - 187KB) Revised Draft Guidance 10/09/18
Generics Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry (PDF - 235KB) Draft Guidance 10/09/18
Procedural Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act. (PDF - 194KB) Draft Guidance (revised final) 10/02/18
Pharmaceutical Quality/CMC Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF - 167KB) Final Guidance 10/02/18
Clinical / Medical Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs (PDF - 71KB) Final Guidance 10/02/18
Procedural Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications Guidance for Industry and FDA Staff (PDF - 457KB) Draft Guidance 09/28/18
Procedural Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry (PDF - 479KB) Draft Guidance 09/28/18
Clinical / Medical Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 623KB) Draft Guidance 09/28/18
Compounding/Drug Safety Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 434KB) Final Guidance 09/28/18
Procedural / Compounding Insanitary Conditions at Compounding Facilities Guidance for Industry (PDF - 343KB) Draft Guidance 09/25/18
Compounding Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry (PDF - 307KB) Final Guidance 09/25/18
Compounding Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (PDF - 324KB) Final Guidance 09/25/18
Procedural Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications (PDF - 98KB) Revised Draft Guidance 09/24/18
Generics /User Fees ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 308KB) Final 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 - 157KB) 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 - 292KB) 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

Page Last Updated: 10/16/2018
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