Newly Added Guidance Documents

Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality Control of Nitrosamine Impurities in Human Drugs Final 9/5/2024 ICH – Multidisciplinary M12 Drug Interaction Studies: Questions and Answers Final 8/2/2024 Electronic Submissions Providing Over-the-Counter Monograph Submissions in Electronic Format Final 7/25/2024 Real World Data / Real World Evidence (RWD/RWE) Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products Final 7/25/2024 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 Generic Drugs, Drug Competition Action Plan Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Final 8/20/2024 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 Final 8/2/2024 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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