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                Guidances | Drugs

Guidances | Drugs

                        Product-Specific Guidances for Generic Drug Development
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          Guidances | Drugs
          Newly Added Guidance DocumentsGuidances | Drugs Newly Added Guidance Documents
  
  	
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    PrintBelow 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

Topic
			Guidance
			Status
			DateClinical - Medical
			Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
			Draft
			1/30/2024Generic Drugs
			Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry
			Final
			1/24/2024Generic Drugs
			Requests for Reconsideration at the Division Level Under GDUFA
			Draft
			1/10/2024ICH-Quality
			Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
			Final
			1/10/2024Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
			Final
			12/28/2023Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Quality Considerations for Topical Ophthalmic Drug Products
			Draft
			12/27/2023Advertising
			Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers
			Final
			12/26/2023Rare Diseases
			Rare Diseases: Considerations for the Development of Drugs and Biological Products
			Final
			12/26/2023Real World Data / Real World Evidence (RWD/RWE), Clinical - Medical
			Data Standards for Drug and Biological Product Submissions Containing Real-World Data
			Final
			12/22/2023Clinical - Medical
			Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
			Final
			12/22/2023Clinical - Medical
			Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
			Final
			12/22/2023Clinical - Medical
			Master Protocols for Drug and Biological Product Development
			Draft
			12/21/2023Clinical - Medical
			Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization
			Final
			12/21/2023Compounding
			Advanced Manufacturing Technologies Designation Program
			Draft
			12/13/2023Compounding
			Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Revision 2
			Draft
			12/06/2023Compounding
			Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
			Draft
			12/06/2023Compounding
			Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Revision 2
			Draft
			12/06/2023Pharmacology/Toxicology
			Translation of Good Laboratory Practice Study Reports: Questions and Answer
			Draft
			11/21/2023Technical Specifications Document
			Submitting Patient-Reported Outcome Data in Cancer Clinical Trials
			Final
			11/06/2023Technical Specifications Document
			Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory
			Final
			11/06/2023Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
			Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
			Draft
			10/26/2023Administrative/Procedural
			Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers
			Draft
			10/24/2023Current Good Manufacturing Practice (CGMP)
			Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
			Final
			10/17/2023Clinical/Antimicrobial
			Diabetic Foot Infections: Developing Drugs for Treatment
			Draft
			10/17/2023Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Quality Considerations for Topical Ophthalmic Drug Products
			Draft
			10/13/2023Clinical - Medical
			Stimulant Use Disorders: Developing Drugs for Treatment
			Draft
			10/05/2023Labeling
			Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
			Final
			10/02/2023Administrative/Procedural
			Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
			Draft
			9/22/2023Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
			Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
			Draft
			9/22/2023Emergencies
			Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies
			Final
			9/21/2023Labeling
			Regulatory Considerations for Prescription Drug Use-Related Software
			Draft
			9/19/2023Clinical - Medical
			Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
			Draft
			9/19/2023Biosimilars
			Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1)
			Draft
			9/18/2023Biosimilars
			Labeling for Biosimilar and Interchangeable Biosimilar Products
			Draft
			9/18/2023Food & Drug Administration Modernization Act of 1997
			Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
			Final
			9/15/2023Clinical - Pharmacology
			Clinical Pharmacology Considerations for Peptide Drug Products
			Draft
			9/11/2023Good Clinical Practice (GCP)
			Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
			Final
			9/11/2023Clinical - Medical
			Endogenous Cushing’s Syndrome: Developing Drugs for Treatment
			Draft
			9/08/2023Generics
			Post-Warning Letter Meetings Under GDUFA
			Draft
			9/05/2023Administrative/Procedural
			Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies
			Final
			9/01/2023Real World Data / Real World Evidence (RWD/RWE), Clinical - Medical
			Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
			Final
			8/30/2023Administrative/Procedural
			Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
			Final
			8/30/2023Administrative/Procedural
			Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies
			Final
			8/28/2023Biosimilars
			Classification Categories for Certain Supplements Under BsUFA III
			Draft
			8/11/2023Biosimilars
			Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
			Draft
			8/11/2023User Fees
			PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR
			Draft
			8/03/2023Administrative/Procedural
			Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act
			Final
			8/03/2023Administrative/Procedural
			Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief
			Draft
			8/02/2023Drug Competition Action Plan, Administrative/Procedural
			CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
			Final
			7/26/2023FDAAA
			Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act
			Draft
			7/14/2023Clinical - Medical
			Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development
			Draft
			7/12/2023Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals
			Final
			5/01/2021Clinical - Medical
			Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment
			Final
			6/29/2023Compounding
			Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act
			Draft
			6/27/2023Advertising
			Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements
			Final
			6/27/2023Clinical - Medical
			Psychedelic Drugs: Considerations for Clinical Investigations
			Draft
			6/23/2023Administrative/Procedural
			Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act
			Draft
			6/23/2023Clinical - Medical
			Clinical Drug Interaction Studies with the Combined Oral Contraceptives Guidance for Industry
			Final
			6/8/2023ICH-Efficacy
			E6(R3) GOOD CLINICAL PRACTICE (GCP)
			Draft
			6/7/2023Generic Drugs
			Cover Letter Attachments for Controlled Correspondences and ANDA Submissions
			Final
			6/05/2023Pharmacology/Toxicology
			Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals
			Final
			6/05/2023Clinical - Medical
			Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment
			Draft
			6/02/2023Clinical - Medical
			Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry
			Final
			6/02/2023Clinical - Medical
			Migraine: Developing Drugs for Preventive Treatment
			Draft
			6/01/2023Clinical - Medical
			Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products
			Draft
			5/26/2023Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
			Final
			5/25/2023Electronic Submissions
			Study Data Technical Conformance Guide - Technical Specifications Document
			Final
			5/24/2023Pharmacology/Toxicology
			Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
			Final
			5/25/2023Pharmacology/Toxicology
			Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information
			Draft
			5/25/2023Administrative/Procedural
			Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations
			Draft
			5/18/2023Administrative/Procedural
			Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
			Draft
			5/18/2023Compliance
			Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
			Final
			5/8/2023User Fees
			Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022
			Final
			5/1/2023ICH - Quality
			Q9(R1) Quality Risk Management
			Final
			5/3/2023Clinical - Medical
			Decentralized Clinical Trials for Drugs, Biological Products, and Devices
			Draft
			5/3/2023ICH-Safety
			S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS
			Final
			5/1/2023Clinical - Medical
			Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products
			Final
			5/1/2023Animal Rule
			Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
			Draft
			4/20/2023Over the Counter
			Over-the-Counter Monograph Order Requests: Format and Content
			Draft
			4/13/2023Generics
			Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
			Draft
			4/13/2023Generics
			Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry
			Draft
			4/13/2023Administrative/Procedural
			A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
			Final
			4/12/2023Administrative/Procedural
			Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
			Draft
			4/5/2023Administrative/Procedural
			Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act
			Draft
			4/5/2023Electronic Submissions
			Identification of Medicinal Products — Implementation and Use
			Final
			3/30/2023Administrative/Procedural
			Pharmacogenomic Data Submissions
			Draft
			3/17/2023Clinical - Medical
			Development of Local Anesthetic Drug Products With Prolonged Duration of Effect
			Draft
			3/15/2023Administrative/Procedural
			Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
			Draft
			3/15/2023ICH - Quality
			Q13 Continuous Manufacturing of Drug Substances and Drug Products
			Final
			3/1/2023Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
			Draft
			3/1/2023Clinical - Medical
			Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment
			Draft
			2/24/2023Generics
			Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
			Draft
			2/17/2023ICH - Multidisciplinary
			M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
			Draft
			1/31/2023Real World Data/Real World Evidence (RWD/RWE)
			Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
			Draft
			1/31/2023Clinical - Pharmacology
			Acromegaly: Developing Drugs for Treatment
			Draft
			1/30/2023Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry
			Final
			1/23/2023Clinical - Medical
			Mpox: Development of Drugs and Biological Products
			Draft
			1/19/2023Labeling
			Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format
			Draft
			1/12/2023Drug Safety
			Format and Content of a REMS Document
			Final
			1/4/2023ICH - Multidisciplinary
			M11 Template: Clinical Electronic Structured Harmonised Protocol
			Draft
			12/21/2022ICH - Multidisciplinary
			M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol
			Draft
			12/21/2022ICH - Multidisciplinary
			M11 Clinical Electronic Structured Harmonised Protocol
			Draft
			12/21/2022Generic Drugs
			Controlled Correspondence Related to Generic Drug Development
			Draft
			12/21/2022Labeling
			Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
			Final
			12/15/2022Clinical-Antimicrobial
			Pulmonary Tuberculosis: Developing Drugs for Treatment
			Draft
			12/14/2022Generics
			Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
			Final
			12/14/2022Compliance
			Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry
			Final
			12/7/2022Clinical - Medical
			Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
			Draft
			12/6/2022ICH-Safety
			E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
			Final
			12/5/2022Generics
			Statistical Approaches to Establishing Bioequivalence
			Draft
			12/2/2022Generics
			ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
			Draft
			12/2/2022Clinical-Antimicrobial
			Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act
			Final
			11/18/2022ICH-Quality
			Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
			Draft
			11/10/2022Generics
			Sameness Evaluations in an ANDA — Active Ingredients
			Draft
			11/8/2022Clinical - Medical
			M10 Bioanalytical Method Validation and Study Sample Analysis
			Final
			11/4/2022Clinical - Medical
			Cross Labeling Oncology Drugs in Combination Regimens
			Final
			11/2/2022ICH-Safety
			S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
			Final
			11/2/2022User Fees
			Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
			Draft
			11/1/2022Clinical - Medical
			Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
			Draft
			10/31/2022Clinical - Antimicrobial
			Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention
			Draft
			10/27/2022Administrative/Procedural
			Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
			Final
			10/27/2022Generics
			Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
			Draft
			10/21/2022Generics
			In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs
			Draft
			10/21/2022Generics
			In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
			Draft
			10/21/2022Generics
			Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
			Draft
			10/21/2022Biostatistics
			Multiple Endpoints in Clinical Trials
			Final
			10/20/2022Clinical - Medical
			Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
			Final
			10/13/2022Generics
			Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
			Final
			10/5/2022Generics
			Competitive Generic Therapies
			Final
			10/5/2022Generics
			Facility Readiness: Goal Date Decisions Under GDUFA
			Draft
			10/3/2022Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
			Draft
			10/3/2022Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
			Final
			10/3/2022Electronic Submissions
			Providing Over-the-Counter Monograph Submissions in Electronic Format
			Draft
			9/27/2022Administrative/Procedural
			Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry
			Final
			9/22/2022Administrative/Procedural
			How To Obtain a Covered Product Authorization
			Draft
			9/21/2022Labeling
			Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products
			Draft
			9/8/2022Labeling
			Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products
			Draft
			9/8/2022Real World Data/Real World Evidence (RWD/RWE)
			Administrative/Procedural
			Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
			Final
			9/8/2022E11A Pediatric Extrapolation
			Draft
			8/26/2022ICH-Multidisciplinary
			M12 Drug Interaction Studies
			Draft
			8/26/2022ICH-Quality
			Q14 Analytical Procedure Development
			Draft
			8/26/2022ICH-Quality
			Q2(R2) Validation of Analytical ProceduresQ14 Analytical Procedure Development
			Draft
			8/26/2022ICH-Efficacy, ICH-Safety
			E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers
			Final
			8/26/2022Generics
			In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs
			Draft
			10/21/2022Generics
			In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
			Draft
			10/21/2022Generics
			Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
			Draft
			10/21/2022Biostatistics
			Multiple Endpoints in Clinical Trials
			Final
			10/20/2022Clinical - Medical
			Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
			Final
			10/13/2022Generics
			Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
			Final
			10/5/2022Generics
			Competitive Generic Therapies
			Final
			10/5/2022Generics
			Facility Readiness: Goal Date Decisions Under GDUFA
			Draft
			10/3/2022Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
			Draft
			10/3/2022Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC)
			Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
			Final
			10/3/2022Electronic Submissions
			Providing Over-the-Counter Monograph Submissions in Electronic Format
			Draft
			9/27/2022Administrative/Procedural
			Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry
			Final
			9/22/2022Administrative/Procedural
			How To Obtain a Covered Product Authorization
			Draft
			9/21/2022Labeling
			Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products
			Draft
			9/8/2022Labeling
			Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products
			Draft
			9/8/2022Real World Data/Real World Evidence (RWD/RWE)
			Administrative/Procedural
			Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
			Final
			9/8/2022E11A Pediatric Extrapolation
			Draft
			8/26/2022ICH-Multidisciplinary
			M12 Drug Interaction Studies
			Draft
			8/26/2022

                                                                                  Content current as of:
      01/29/2024
              
              
Regulated Product(s)
		 DrugsGuidances | Drugs

          
                        Product-Specific Guidances for Generic Drug Development
          Guidance Snapshot Pilot
 
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