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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

Topic Guidance Status Date
Biologics Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers Draft 7/23/2024
Clinical - Medical Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment Draft 7/19/2024
Clinical - Pharmacology Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Final 7/18/2024
Clinical - Pharmacology Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older Guidance for Industry Final 7/15/2024
Combination Products Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products Draft 7/08/2024
ICH - Multidisciplinary M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines Draft 7/05/2024
Biosimilars Considerations in Demonstrating Interchangeability With a Reference Product: Update Draft 6/21/2024
Generic Drugs Facility Readiness: Goal Date Decisions Under GDUFA Final 6/18/2024
Clinical/Antimicrobial Diabetic Foot Infections: Developing Drugs for Treatment Final 6/17/2024
Clinical - Medical Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Final 6/14/2024
Safety - Issues, Errors, and Problems REMS Logic Model: A Framework to Link Program Design With Assessment Draft 5/07/2024
Generic Drugs Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs Draft 4/29/2024
Drugs Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry Draft 4/24/2024
Generic Drugs Data Integrity for In Vivo Bioavailability and Bioequivalence Studies Draft 4/03/2024
Generic Drugs Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry Final 4/01/2024
Electronic Submissions Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry Final 4/01/2024
Generic Drugs Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples Draft 3/27/2024
Real World Data / Real World Evidence (RWD/RWE) Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products Draft 3/21/2024
Generic Drugs Controlled Correspondence Related to Generic Drug Development Final 3/18/2024
ICH-Efficacy E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports Draft 3/13/2024
Labeling Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products Draft 3/13/2024
Clinical - Medical Early Alzheimer’s Disease: Developing Drugs for Treatment Draft 3/12/2024
ICH-Quality Q14 Analytical Procedure Development Final 3/07/2024
Clinical - Pharmacology Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry Final 3/01/2024
ICH-Quality Q2(R2) Validation of Analytical Procedures Final 3/06/2024
Administrative/Procedural Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft 2/29/2024
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 2/22/2024
Procedural Charging for Investigational Drugs Under an IND: Questions and Answers Final 2/14/2024
Clinical - Medical Use of Data Monitoring Committees in Clinical Trials Draft 2/13/2024
Administrative/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 2/06/2024
Administrative/Procedural Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Final 2/05/2024
Clinical - Medical Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products Draft 1/30/2024
Generic Drugs Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry Final 1/24/2024

Generic Drugs

Requests for Reconsideration at the Division Level Under GDUFA Draft 1/10/2024

ICH-Quality

Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Final 1/10/2024
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Reformulating Drug Products That Contain Carbomers Manufactured With Benzene Final 12/28/2023
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Quality Considerations for Topical Ophthalmic Drug Products Draft 12/27/2023
Advertising 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 12/26/2023
Rare Diseases Rare Diseases: Considerations for the Development of Drugs and Biological Products Final 12/26/2023
Real World Data / Real World Evidence (RWD/RWE), Clinical - Medical Data Standards for Drug and Biological Product Submissions Containing Real-World Data Final 12/22/2023
Clinical - Medical Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Final 12/22/2023
Clinical - Medical Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products Final 12/22/2023
Clinical - Medical Master Protocols for Drug and Biological Product Development Draft 12/21/2023
Clinical - Medical Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization Final 12/21/2023
Compounding Advanced Manufacturing Technologies Designation Program Draft 12/13/2023
Compounding Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Revision 2 Draft 12/06/2023
Compounding Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Draft 12/06/2023
Compounding Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Revision 2 Draft 12/06/2023
Pharmacology/Toxicology Translation of Good Laboratory Practice Study Reports: Questions and Answer Draft 11/21/2023
Technical Specifications Document Submitting Patient-Reported Outcome Data in Cancer Clinical Trials Final 11/06/2023
Technical Specifications Document Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory Final 11/06/2023
Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities Draft 10/26/2023
Administrative/Procedural Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers Draft 10/24/2023
Current Good Manufacturing Practice (CGMP) Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol Final 10/17/2023
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Quality Considerations for Topical Ophthalmic Drug Products Draft 10/13/2023
Clinical - Medical Stimulant Use Disorders: Developing Drugs for Treatment Draft 10/05/2023
Labeling Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” Final 10/02/2023
Administrative/Procedural Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Draft 9/22/2023
Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Draft 9/22/2023
Emergencies Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies Final 9/21/2023
Labeling Regulatory Considerations for Prescription Drug Use-Related Software Draft 9/19/2023
Clinical - Medical Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence Draft 9/19/2023
Biosimilars Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1) Draft 9/18/2023
Biosimilars Labeling for Biosimilar and Interchangeable Biosimilar Products Draft 9/18/2023
Food & 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 9/15/2023
Clinical - Pharmacology Clinical Pharmacology Considerations for Peptide Drug Products Draft 9/11/2023
Good Clinical Practice (GCP) Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products Final 9/11/2023
Clinical - Medical Endogenous Cushing’s Syndrome: Developing Drugs for Treatment Draft 9/08/2023
Generics Post-Warning Letter Meetings Under GDUFA Draft 9/05/2023
Administrative/Procedural Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies Final 9/01/2023
Real 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 8/30/2023
Administrative/Procedural Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Final 8/30/2023
Administrative/Procedural Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies Final 8/28/2023
Biosimilars

Classification Categories for Certain Supplements Under BsUFA III

Draft 8/11/2023
Biosimilars

Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry

Draft 8/11/2023
User Fees PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR Draft 8/03/2023
Administrative/Procedural Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Final 8/03/2023
Administrative/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 8/02/2023
Drug Competition Action Plan, Administrative/Procedural CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Final 7/26/2023
FDAAA 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 7/14/2023
Clinical - Medical Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development Draft 7/12/2023
  Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals Final 5/01/2021
Clinical - Medical Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment Final 6/29/2023
Compounding Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act Draft 6/27/2023
Advertising Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements Final 6/27/2023
Clinical - Medical Psychedelic Drugs: Considerations for Clinical Investigations Draft 6/23/2023
Administrative/Procedural Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act Draft 6/23/2023
Clinical - Medical Clinical Drug Interaction Studies with the Combined Oral Contraceptives Guidance for Industry Final 6/8/2023
ICH-Efficacy E6(R3) GOOD CLINICAL PRACTICE (GCP) Draft 6/7/2023
Generic Drugs Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Final 6/05/2023
Pharmacology/Toxicology Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals Final 6/05/2023
Clinical - Medical Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment Draft 6/02/2023
Clinical - Medical Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry Final 6/02/2023
Clinical - Medical Migraine: Developing Drugs for Preventive Treatment Draft 6/01/2023
Clinical - Medical Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Draft 5/26/2023
  Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Final 5/25/2023
Electronic Submissions Study Data Technical Conformance Guide - Technical Specifications Document Final 5/24/2023
Pharmacology/Toxicology Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Final 5/25/2023
Pharmacology/Toxicology Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information Draft 5/25/2023
Administrative/Procedural Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations Draft 5/18/2023
Administrative/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 5/18/2023
Compliance 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 5/8/2023
User Fees Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 Final 5/1/2023
ICH - Quality Q9(R1) Quality Risk Management Final 5/3/2023
Clinical - Medical Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft 5/3/2023
ICH-Safety S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS Final 5/1/2023
Clinical - Medical Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products Final 5/1/2023
Animal Rule Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment Draft 4/20/2023
Over the Counter Over-the-Counter Monograph Order Requests: Format and Content Draft 4/13/2023
Generics Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Draft 4/13/2023
Generics Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry Draft 4/13/2023
Administrative/Procedural A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Final 4/12/2023
Administrative/Procedural Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making Draft 4/5/2023
Administrative/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 4/5/2023
Electronic Submissions Identification of Medicinal Products — Implementation and Use Final 3/30/2023
Administrative/Procedural Pharmacogenomic Data Submissions Draft 3/17/2023
Clinical - Medical Development of Local Anesthetic Drug Products With Prolonged Duration of Effect Draft 3/15/2023
Administrative/Procedural Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers Draft 3/15/2023
ICH - Quality  Q13 Continuous Manufacturing of Drug Substances and Drug Products Final 3/1/2023
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens Draft 3/1/2023
Clinical - Medical Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Draft 2/24/2023
Generics Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Draft 2/17/2023
ICH - Multidisciplinary M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms Draft 1/31/2023
Real World Data/Real World Evidence (RWD/RWE) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft 1/31/2023
Clinical - Pharmacology Acromegaly: Developing Drugs for Treatment Draft 1/30/2023
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry Final 1/23/2023
Clinical - Medical Mpox: Development of Drugs and Biological Products Draft 1/19/2023
Labeling Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Draft 1/12/2023
Drug Safety Format and Content of a REMS Document Final 1/4/2023
ICH - Multidisciplinary M11 Template: Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
ICH - Multidisciplinary M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
ICH - Multidisciplinary M11 Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
Labeling Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims Final 12/15/2022
Clinical-Antimicrobial Pulmonary Tuberculosis: Developing Drugs for Treatment Draft 12/14/2022
Generics Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry Final 12/14/2022
Compliance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry Final 12/7/2022
Clinical - Medical Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations Draft 12/6/2022
ICH-Safety E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials Final 12/5/2022
Generics Statistical Approaches to Establishing Bioequivalence Draft 12/2/2022
Generics ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions Draft 12/2/2022
Clinical-Antimicrobial Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act Final 11/18/2022
ICH-Quality Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Draft 11/10/2022
Generics Sameness Evaluations in an ANDA — Active Ingredients Draft 11/8/2022
Clinical - Medical M10 Bioanalytical Method Validation and Study Sample Analysis Final 11/4/2022
Clinical - Medical Cross Labeling Oncology Drugs in Combination Regimens Final 11/2/2022
ICH-Safety S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals Final 11/2/2022
User Fees Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program Draft 11/1/2022
Clinical - Medical Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials Draft 10/31/2022
Clinical - Antimicrobial Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention Draft 10/27/2022
Administrative/Procedural Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products Final 10/27/2022
Generics Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Draft  10/21/2022
Generics In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Biostatistics Multiple Endpoints in Clinical Trials Final 10/20/2022
Clinical - Medical Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA Final 10/13/2022
Generics Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA  Final 10/5/2022
Generics Competitive Generic Therapies Final 10/5/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Final 10/3/2022
Electronic Submissions Providing Over-the-Counter Monograph Submissions in Electronic Format Draft 9/27/2022
Administrative/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 9/22/2022
Administrative/Procedural How To Obtain a Covered Product Authorization Draft 9/21/2022
Labeling Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products Draft 9/8/2022
Labeling Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products Draft 9/8/2022
Real 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 9/8/2022
  E11A Pediatric Extrapolation Draft 8/26/2022
ICH-Multidisciplinary  M12 Drug Interaction Studies Draft 8/26/2022
ICH-Efficacy, ICH-Safety E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Final 8/26/2022    
Generics In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Biostatistics Multiple Endpoints in Clinical Trials Final 10/20/2022
Clinical - Medical Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA Final 10/13/2022
Generics Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA  Final 10/5/2022
Generics Competitive Generic Therapies Final 10/5/2022
Generics Facility Readiness: Goal Date Decisions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Final 10/3/2022
Electronic Submissions Providing Over-the-Counter Monograph Submissions in Electronic Format Draft 9/27/2022
Administrative/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 9/22/2022
Administrative/Procedural How To Obtain a Covered Product Authorization Draft 9/21/2022
Labeling Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products Draft 9/8/2022
Labeling Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products Draft 9/8/2022
Real 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 9/8/2022
  E11A Pediatric Extrapolation Draft 8/26/2022
ICH-Multidisciplinary  M12 Drug Interaction Studies Draft 8/26/2022
 
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