Newly Added Guidance Documents | FDA

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 DocumentsTopicGuidanceStatusDateICH-QualityQ3E Guideline for Extractables and LeachablesDraft12/1/2025ICH-QualityQE3 Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable MonographsDraft12/1/2025Current Good Manufacturing Practice (CGMP), Pharmaceutical QualityCurrent Good Manufacturing Practice for Medical GasesDraft12/1/2025Generic DrugsConsiderations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic UseFinal11/17/2025BiosimilarsScientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy StudiesDraft10/29/2025Administrative/ProceduralExpanded Access to Investigational Drugs for Treatment Use: Questions and AnswersFinal10/22/2025Administrative/ProceduralPatient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome AssessmentsFinal10/22/2025ICH-EfficacyE20 Adaptive Designs for Clinical TrialsDraft9/30/2025Clinical - AntimicrobialMalaria: Developing Drugs for TreatmentDraft9/23/2025LabelingSafety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C ActDraft9/18/2025Clinical - AntimicrobialDisseminated Coccidioidomycosis: Developing Drugs for TreatmentDraft9/17/2025Clinical - MedicalSymptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for TreatmentDraft9/17/2025Clinical - MedicalErosive Esophagitis: Developing Drugs for TreatmentDraft9/17/2025Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP)Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending ApplicationsFinal9/12/2025Clinical - MedicalDevelopment of Non-Opioid Analgesics for Chronic PainDraft9/11/2025ICH-EfficacyE6(R3) Good Clinical Practice (GCP)Final9/9/2025BiosimilarsDevelopment of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related ConsiderationsFinal9/9/2025BiosimilarsFormal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for IndustryFinal7/18/2025ICH-QualityE21 Inclusion of Pregnant and Breastfeeding Women in Clinical TrialsDraft7/18/2025Clinical - MedicalSmall Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling RecommendationsDraft7/3/2025Clinical - AntimicrobialAntibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and AnswersFinal6/26/2025Clinical - AntimicrobialEarly Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for TreatmentFinal6/26/2025ICH-QualityQ1 Stability Testing of Drug Substances and Drug ProductsDraft6/23/2025Generic DrugsPost-Warning Letter Meetings Under GDUFAFinal6/20/2025Pharmaceutical Quality; Chemistry, Manufacturing, and Controls (CMC)ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug SubmissionsFinal6/13/2025ICH-MultidisciplinaryM11 Technical Specification: Clinical Electronic Structured Harmonised ProtocolDraft6/5/2025ICH-MultidisciplinaryM11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)Draft6/5/2025Over-the-Counter DrugsRecommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph DrugsDraft6/4/2025ICH-MultidisciplinaryM13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths BiowaiverDraft6/2/2025Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC)Replacing Color Additives in Approved or Marketed Drug ProductsDraft5/29/2025Clinical - MedicalObesity and Overweight: Developing Drugs and Biological Products for Weight ReductionDraft1/7/2025Clinical - MedicalDeveloping Drugs for Optical ImagingDraft1/7/2025Clinical - MedicalStudy of Sex Differences in the Clinical Evaluation of Medical ProductsDraft1/6/2025Compounding and Related DocumentsInterim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic ActFinal1/6/2025Compounding and Related DocumentsInterim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic ActFinal1/6/2025Artificial IntelligenceConsiderations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological ProductsDraft1/7/2025Administrative/ProceduralCommunications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and AnswersDraft1/6/2025Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP)Considerations for Complying with 21 CFR 211.110Draft1/6/2025Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC)Advanced Manufacturing Technologies Designation ProgramFinal12/31/2024ICH - MultidisciplinaryM15 General Principles for Model-Informed Drug DevelopmentDraft12/30/2024ICH - EfficacyE11A Pediatric ExtrapolationFinal12/30/2024ICH - EfficacyE6(R3) Good Clinical Practice: Annex 2Draft12/30/2024Clinical - MedicalProtocol Deviations for Clinical Investigations of Drugs, Biological Products, and DevicesDraft12/30/2024Technical Specifications DocumentTechnical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)\Final12/13/2024ProceduralAccelerated Approval – Expedited Program for Serious ConditionsDraft12/5/2024ICH - MultidisciplinaryM13A Bioequivalence for Immediate-Release Solid Oral Dosage FormsFinal10/30/2024Labeling / Clinical PharmacologyDrug Interaction Information in Human Prescription Drug and Biological Product LabelingDraft10/21/2024Clinical - MedicalPostoperative Nausea and Vomiting: Developing Drugs for PreventionDraft10/17/2024User FeesRequests for Reconsideration at the Division Level Under GDUFAFinal10/16/2024CompoundingTemporary Policies for Compounding Certain Parenteral Drug ProductsFinal10/11/2024Administrative / ProceduralElectronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and AnswersFinal10/1/2024Clinical - MedicalConducting Clinical Trials With Decentralized ElementsFinal9/17/2024Real World Data / Real World Evidence (RWD/RWE)Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical PracticeDraft9/17/2024Electronic SubmissionsProviding Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for IndustryFinal9/11/2024Generic DrugsANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFAFinal9/11/2024Current Good Manufacturing Practice (CGMP), Pharmaceutical QualityControl of Nitrosamine Impurities in Human DrugsFinal9/5/2024ICH - MultidisciplinaryM12 Drug Interaction Studies: Questions and AnswersFinal8/2/2024Electronic SubmissionsProviding Over-the-Counter Monograph Submissions in Electronic FormatFinal7/25/2024Real 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 ProductsFinal7/25/2024BiologicsPostapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and AnswersDraft7/23/2024Clinical - MedicalPediatric Inflammatory Bowel Disease: Developing Drugs for TreatmentDraft7/19/2024Clinical - PharmacologyClinical Pharmacology Considerations for Human Radiolabeled Mass Balance StudiesFinal7/18/2024Clinical - PharmacologyDrugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older Guidance for IndustryFinal7/15/2024Combination ProductsPurpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination ProductsDraft7/08/2024ICH - MultidisciplinaryM14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of MedicinesDraft7/05/2024