|
|
|
|
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications Revision 7 |
Final |
2/21/2020 |
| Pharm / Tox |
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry |
Revised Draft |
2/19/2020 |
| Biosimilarity |
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry |
Draft |
2/06/2020 |
| Clinical / Medical |
Mucopolysaccharidosis Type III (Sanfilippo Syndrome):Developing Drugs for Treatment Guidance for Industry |
Draft |
2/04/2020 |
| Advertising |
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry |
Draft |
2/03/2020 |
| Clinical/ Medical |
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry |
Final |
1/24/2020 |
| User Fees |
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry |
Final |
1/23/2020 |
| Combination Products |
Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry |
Draft |
12/18/2019 |
| Drug Development Tools; Clinical/Medical |
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff |
Draft |
12/13/2019 |
| Clinical/Medical |
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry |
Draft |
12/06/2019 |
| 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 |
