|
| User Fees |
Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act |
Final |
4/03/2020 |
| Procedural |
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
Final |
3/27/2020 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP)/Over-the-Counter (OTC) |
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry |
Final |
3/24/2020 |
| Clinical / Medical |
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
Final |
3/22/2020 |
| Clinical / Medical |
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) |
Final |
3/19/2020 |
| Drug Safety |
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic |
Final |
3/19/2020 |
| Clinical / Medical |
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic |
Final |
3/18/2020 |
| Compounding |
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency |
Final |
3/14/2020 |
| Drug Safety |
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry |
Draft |
3/17/2020 |
| Genetics |
Competitive Generic Therapies Guidance for Industry |
Final |
3/13/2020 |
| Rare Diseases |
Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry |
Final |
3/13/2020 |
| ICH - Quality |
Q3D(R1) Elemental Impurities Guidance for Industry |
Final |
3/10/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Draft |
3/10/2020 |
| Clinical / Medical |
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control |
Draft |
3/9/2020 |
| Clinical / Medical |
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry |
Draft |
3/6/2020 |
| Pharmacology / Toxicology |
Safety Testing of Drug Metabolites Guidance for Industry |
Final, Revision 2 |
3/5/2020 |
| Procedural |
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers |
Final |
3/4/2020 |
| 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 |
| Genetics |
Competitive Generic Therapies Guidance for Industry |
Final |
3/13/2020 |
| Rare Diseases |
Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry |
Final |
3/13/2020 |
| ICH - Quality |
Q3D(R1) Elemental Impurities Guidance for Industry |
Final |
3/10/2020 |
| Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Draft |
3/10/2020 |
| Clinical / Medical |
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control |
Draft |
3/9/2020 |
| Clinical / Medical |
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry |
Draft |
3/6/2020 |
| Pharmacology / Toxicology |
Safety Testing of Drug Metabolites Guidance for Industry |
Final, Revision 2 |
3/5/2020 |
| Procedural |
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers |
Final |
3/4/2020 |
| 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 |
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 |
