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.

Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 127KB) Final Guidance 12/12/18
Drug Development Tools Biomarker Qualification: Evidentiary Framework (PDF - 346KB) Draft Guidance 12/11/18
Procedural The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers (PDF - 427KB) Draft Guidance 12/11/18
Procedural Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (PDF - 410KB) Final Guidance 12/11/18
Biosimilarity New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (PDF - 679KB) Draft Guidance 12/11/18
Biosimilars Questions and Answers on Biosimilar Development and the BPCI Act (PDF - 343KB) Final Guidance 12/11/18
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF - 476KB) Draft Guidance 12/10/18
Clinical/Medical Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment (PDF - 98KB) Draft Guidance 12/03/18
Generics / User Fees Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA (PDF - 101KB) Final Guidance 12/03/18
Clinical / Medical Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials (PDF - 72KB) Draft Guidance 11/13/18
Drug Safety; Biostatistics Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry (PDF - 227KB) Draft Guidance 11/06/18
Clinical / Medical Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry (PDF - 96KB) Final Guidance 11/06/18
Clinical / Antimicrobial Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment (PDF - 507KB) Draft Guidance 11/01/18
ICH – Multidisciplinary M9 Biopharmaceutics Classification System-Based Biowaivers (PDF - 460KB) Draft Guidance 10/25/18
Procedural Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (PDF - 357KB) Draft Guidance 10/24/18
Clinical / Medical; Pharmacology / Toxicology Testicular Toxicity: Evaluation During Drug Development Guidance for Industry (PDF - 180KB) Final Guidance 10/24/18
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; Biostatistics 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

Page Last Updated: 12/12/2018
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