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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

Category Title Type Issue date
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