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.

International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk (PDF - 1.4MB) Final Guidance 03/13/18
ICH - Efficacy E18 Genomic Sampling and Management of Genomic Data Guidance for Industry (PDF - 98KB) Final Guidance 03/01/18
Procedural Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (PDF - 283KB) Draft Guidance 02/28/18
Procedural Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF - 170KB) Draft Guidance 02/28/18
International Council on Harmonisation - Efficacy E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (PDF - 484KB) Final Guidance 02/28/18
International Council on Harmonisation - Quality Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) (PDF - 843KB) Final Guidance 02/23/18
Clinical/Medical Migraine: Developing Drugs for Acute Treatment (PDF - 115KB) Final Guidance 02/15/18
Clinical / Medical Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry (PDF - 119KB) Final Guidance 02/15/18
Clinical / Medical Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment (PDF - 132KB) Draft Guidance 02/15/18
Clincal / Medical Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy (PDF - 61KB) Draft Guidance 02/15/18
Clinical / Medical Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older (PDF - 51KB) Draft Guidance 02/15/18
Pharmaceutical Quality/CMC Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 87KB) Revised Final Guidance 02/14/18
Clinical / Medical Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry (PDF - 96KB) Final Guidance 02/12/18
Clinical / Antimicrobial Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF - 162KB) Final Guidance 02/07/18
Procedural Qualified Infectious Disease Product Designation Questions and Answers (PDF - 390KB) Draft Guidance 01/29/18
Clinical / Medical Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry (PDF - 94KB) Draft Guidance 01/25/18
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 556KB) Final Guidance 01/18/18
Compounding Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 553KB) Final Guidance 01/18/18
Compounding Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 468KB) Final Guidance 01/18/18
Labeling Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (PDF - 680KB) Draft Guidance 01/18/18
Generics Good ANDA Submission Practices Guidance for Industry (PDF - 250KB) Draft Guidance 01/03/18
Clinical / Medical Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry (PDF - 109KB) Draft Guidance 01/02/18
Labeling Labeling for Combined Hormonal Contraceptives Guidance for Industry (PDF - 437KB) Draft Guidance 12/29/17
Procedural Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry (PDF - 156KB) Draft Guidance 12/28/17
Procedural Best Practices for Communication Between IND Sponsors and FDA During Drug Development (PDF - 191KB) Final Guidance 12/28/17
Biopharmaceutics Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Guidance for Industry (PDF - 161KB) Final Guidance 12/22/17
Compliance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry (PDF - 78KB) Draft Guidance 12/18/17
Generics / User fees Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry (PDF - 81KB) Draft Guidance 12/15/17
Pharmaceutical Quality / CMC Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (PDF - 235KB) Draft Guidance 12/15/17
Clinical Pharmacology Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry (PDF - 75KB) Draft Guidance 12/15/17
Labeling Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs (PDF - 92KB) Final Guidance 12/13/17
Procedural Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry (PDF - 109KB) Draft Guidance 12/12/17
Labeling Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry (PDF - 136KB) Draft Guidance 12/12/17
Advertising Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (PDF - 115KB) Final Guidance 12/11/17
Rare Diseases Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry (PDF - 262KB) Draft Guidance 12/06/17
Procedural Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF - 393KB) Draft Guidance 11/27/17
Generics General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry (PDF - 520KB) Final Guidance 11/21/17
User Fees Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (PDF - 359KB) Draft Guidance 11/15/17
International Council for Harmonisation - Safety S5(R3) Detection of Toxicity to Reproduction (PDF - 1.4MB) Draft Guidance 11/09/17
Procedural Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry (PDF - 103KB) Draft Guidance 11/08/17
Clinical/Medical Evaluating Drug Effects on the Ability to Operate a Motor Vehicle (PDF - 104KB) Final Guidance 11/08/17
Clinical / Medical Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention (PDF - 153KB) Final Guidance 11/06/17
Compliance Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry (PDF - 193KB) Final Guidance 11/06/17
Clinical / Antimicrobial Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Guidance for Industry (PDF - 258KB) Final Guidance 11/06/17
Pharmaceutical Quality/CMC / Generics ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (PDF - 151KB) Draft Guidance 11/03/17
Procedural Formal Dispute Resolution: Appeals Above the Division Level Guidance for Industy (PDF - 214KB) Final Guidance 11/03/17
Generics - User Fees Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry (PDF - 171KB) Draft Guidance 11/02/17

Page Last Updated: 03/13/2018
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