| Clinical Pharmacology
|
|
Draft
|
11/20/2020
|
| Clinical/ Medical
|
Cross Labeling Oncology Drugs in Combination Drug Regimens Guidance for Industry
|
Draft
|
11/19/2020
|
| Biosimilarity
|
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act Guidance for Industry
|
Draft
|
11/19/2020
|
| User Feed
|
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry
|
Final
|
11/09/2020
|
| Clinical / Medical
|
Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
|
Final
|
11/09/2020
|
| Pharm/tox
|
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry
|
Final
|
10/28/2020
|
| Generics
|
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry
|
Final
|
10/27/2020
|
| Procedural
|
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies Guidance for Industry
|
Final
|
10/22/2020
|
| Drug Safety
|
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
|
Draft
|
10/20/2020
|
| Clinical/Medical
|
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry
|
Final
|
10/01/2020
|
| Phamaceutical Quality/CMC
|
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry
|
Draft
|
9/30/2020
|
| ICH-Safety /ICH-Efficacy
|
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Guidance for Industry
|
Draft
|
9/29/2020
|
| Generics
|
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
|
Draft
|
9/28/2020
|
| Generics
|
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
|
Final
|
9/28/2020
|
| ICH-Multidisciplinary
|
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Questions and Answers
|
Draft
|
9/28/2020
|
| Labeling
|
Geriatric Information in Human Prescription Drug and Biological Product Labeling
|
Draft
|
9/15/2020
|
| Clinical/Medical
|
Eosinophilic Esophagitis: Developing Drugs for Treatment
|
Final
|
9/15/2020
|
| COVID-19 Clinical/Medical
|
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
|
Final
|
9/14/2020
|
| COVID-19
|
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
|
Final
|
9/10/2020
|
| Pharmaceutical Quality / CGMP
|
Control of Nitrosamine Impurities in Human Drugs Guidance for Industry
|
Final
|
9/01/2020
|
| COVID-19
|
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry
|
Final
|
8/19/2020
|
| Procedural, Generics
|
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Guidance for Industry
|
Final
|
8/18/2020
|
| Procedural
|
Marketing Status Notifications Under Section 506I Guidance for Industry
|
Final
|
8/10/2020
|
| Clinical Pharmacology
|
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry
|
Draft
|
8/7/2020
|
| Procedural
|
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry
|
Final
|
8/5/2020
|
| Procedural
|
Pediatric Study Plans:Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry
|
Final
|
7/31/2020
|
| Clinical/ Medical
|
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval Guidance for Industry
|
Final
|
7/29/2020
|
| Labeling
|
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry
|
Draft
|
7/29/2020
|
| Pharmaceutical Quality/CGMP
|
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Guidance for Industry
|
Final
|
7/29/2020
|
| Chemisty, Manufacturing Control (CMC)
|
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry
|
Draft
|
7/28/2020
|
| Pharmaceutical Quality/CMC
|
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry
|
Draft
|
7/21/2020
|
| Clinical / Medical
|
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
|
Final
|
7/10/2020
|
| Clinical / Medical
|
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
|
Final
|
7/10/2020
|
| Clinical / Medical
|
Cancer Clinical Trial Eligibility Criteria: Brain Metastases
|
Final
|
7/10/2020
|
| Clinical / Medical
|
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
|
Final
|
7/10/2020
|
| Clinical / Medical
|
Development of Anti-Infective Drug Products for the Pediatric Population
|
Draft
|
6/29/2020
|
| Drug Safety
|
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry
|
Final
|
6/29/2020
|
| Clinical / Antimicrobial
|
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment
|
Final
|
6/24/2020
|
| Clinical / Antimicrobial
|
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment
|
Final
|
6/24/2020
|
| COVID-19
|
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry
|
Final
|
6/19/2020
|
| COVID-19
|
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
6/17/2020
|
| Procedural
|
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
|
Final
|
6/16/2020
|
| Clincal / Medical
|
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
6/2/2020
|
| Generics
|
Orange Book Questions and Answers Guidance for Industry
|
Draft
|
5/29/2020
|
| ICH -Quality
|
Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents
|
Draft
|
5/26/2020
|
|
|
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products
|
Final
|
5/11/2020
|
| Clinical Medical
|
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
|
Final
|
5/11/2020
|
| Clinical / Antimicrobial
|
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease Guidance for Industry
|
Final
|
5/7/2020
|
| Compounding, Clinical Medical
|
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/30/2020
|
| Compounding
|
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/22/2020
|
| Compounding, Pharmaceutical Quality
|
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/20/2020
|
| Compounding
|
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency
|
Final
|
4/16/2020
|
| Clinical / Medical
|
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate
|
Final
|
4/13/2020
|
| Clinical / Medical
|
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/10/2020
|
| Clinical / Medical
|
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/09/2020
|
| 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
|
2/3/2020
|
| Clinical / Antimicrobial
|
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease Guidance for Industry
|
Final
|
5/7/2020
|
| Compounding, Clinical Medical
|
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/30/2020
|
| Compounding
|
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/22/2020
|
| Compounding, Pharmaceutical Quality
|
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/20/2020
|
| Compounding
|
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency
|
Final
|
4/16/2020
|
| Clinical / Medical
|
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate
|
Final
|
4/13/2020
|
| Clinical / Medical
|
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/10/2020
|
| Clinical / Medical
|
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry
|
Final
|
4/09/2020
|
| 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
|
2/3/2020
|
| Pharmaceutical Quality/CMC
|
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry
|
Draft
|
11/1/2019
|
| 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
|
