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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

 
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
Clinical/Antimicrobial Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF - 120KB) Final 11/15/2019
User Fees Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry Draft 10/31/2019
Clinical / Antimicrobial Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry Draft 10/31/2019
Electronic Submissions Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry Draft 10/29/2019
Electronic Submissions Electronic Submission of IND Safety Reports Technical Conformance Guide Final 10/29/2019
Pharmaceutical Quality/CMC Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Draft 10/28/2019
Drug Safety Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry Draft 10/24/2019
Compliance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry Draft 10/24/2019
Pharmaceutical Quality/CMC Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers Guidance for Industry Draft 10/22/2019
Pharmaceutical Quality/CMC Drug Master Files Guidance for Industry Draft 10/18/2019
User Fees Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry Final 10/16/2019
Procedural Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry (PDF - 68KB) Final 10/09/2019
Pharmaology / toxicology Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment Guidance for Industry Final 10/02/2019
Procedural Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders Draft 9/30/2019
Procedural Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry Final 9/23/2019
Clinical/Medical Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry Final 9/23/2019
Procedural Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry Final 9/18/2019
Clinical/ Medical; Clinical Pharmacology Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older Guidance for Industry Final 9/5/2019
Biopharmaceutical Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers Guidance for Industry Final 9/4/2019
Clinical/Medical Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry Final 8/28/2019
Pharmacology / Toxicology Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry Final 8/14/2019
Labeling Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry Final 8/13/2019
Clinical / Medical Gastroparesis: Clinical Evaluation of Drugs for Treatment. 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
Procedural A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Draft 3/14/2019
Clinical / Medical Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products Final 3/15/2019
Pharmacology / Toxicology Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry Final 3/15/2019
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Brain Metastases Draft 3/13/2019
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients Draft 3/13/2019
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Draft 3/13/2019
Clinical / Medical Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials Draft 3/13/2019
Labeling Nonproprietary Naming of Biological Products: Update Guidance for Industry Draft 3/8/2019
Compounding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Final 3/4/2019
Pharmaceutical Quality / CMC Pharmaceutical Quality/Manufacturing Standards (CGPM) Quality Considerations for Continuous Manufacturing Draft 2/27/2019
Clinical Pharmacology Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations Draft 2/26/2019
Clinical Pharmacology Bioavailability Studies Submitted in NDAs or INDs – General Considerations Draft 2/26/2019
Clinical / Medical Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products Draft 2/22/2019
Generics Competitive Generic Therapies Draft 2/19/2019
Procedural CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Draft 2/14/2019
Clinical / Medical Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment Final 2/7/2019
Clinical / Medical Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry  Draft 2/6/2019
Combination Products Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff Draft 2/6/2019
Clinical / Antimicrobial Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices: Guidance for Industry and Food and Drug Administration Staff Final 2/1/2019
Rare Diseases Rare Diseases: Common Issues in Drug Development Guidance for Industry Draft 2/1/2019
Procedural Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act Draft 1/31/2019
Electronic Submissions Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Final 1/29/2019
Procedural REMS Assessment: Planning and Reporting Draft 1/24/2019
Procedural Survey Methodologies to Assess REMS Goals That Relate to Knowledge Draft 1/24/2019
Pharmaceutical Quality/CMC Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection Final 1/23/2019
Labeling Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway Final 1/22/2019
International Council for Harmonisation - Safety S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines Draft 1/22/2019
Generics ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs Final 1/16/2019