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  1. Guidances | Drugs

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

TopicGuidanceStatusDate
Generic DrugsPost-Warning Letter Meetings Under GDUFAFinal6/20/2025
Pharmaceutical Quality; Chemistry, Manufacturing, and Controls (CMC)ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug SubmissionsFinal6/13/2025
ICH-MultidisciplinaryM11 Technical Specification: Clinical Electronic Structured Harmonised ProtocolDraft6/5/2025
ICH-MultidisciplinaryM11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)Draft6/5/2025
Over-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 DrugsDraft6/4/2025
ICH-MultidisciplinaryM13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths BiowaiverDraft6/2/2025
Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC)Replacing Color Additives in Approved or Marketed Drug ProductsDraft5/29/2025
Clinical - MedicalObesity and Overweight: Developing Drugs and Biological Products for Weight ReductionDraft1/7/2025
Clinical/MedicalDeveloping Drugs for Optical ImagingDraft1/7/2025
Clinical/MedicalStudy of Sex Differences in the Clinical Evaluation of Medical ProductsDraft1/6/2025
Compounding and Related DocumentsInterim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic ActFinal1/6/2025
Compounding and Related DocumentsInterim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic ActFinal1/6/2025
Artificial IntelligenceConsiderations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological ProductsDraft1/7/2025
Administrative/ProceduralCommunications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and AnswersDraft1/6/2025
Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP)Considerations for Complying with 21 CFR 211.110Draft1/6/2025
Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC)Advanced Manufacturing Technologies Designation ProgramFinal12/31/2024
ICH - MultidisciplinaryM15 General Principles for Model-Informed Drug DevelopmentDraft12/30/2024
ICH - EfficacyE11A Pediatric ExtrapolationFinal12/30/2024
ICH - EfficacyE6(R3) Good Clinical Practice: Annex 2Draft12/30/2024
Clinical - MedicalProtocol Deviations for Clinical Investigations of Drugs, Biological Products, and DevicesDraft12/30/2024
Technical Specifications DocumentTechnical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)\Final12/13/2024
ProceduralAccelerated Approval – Expedited Program for Serious ConditionsDraft12/5/2024
ICH - MultidisciplinaryM13A Bioequivalence for Immediate-Release Solid Oral Dosage FormsFinal10/30/2024
Labeling / Clinical PharmacologyDrug Interaction Information in Human Prescription Drug and Biological Product LabelingDraft10/21/2024
Clinical - MedicalPostoperative Nausea and Vomiting: Developing Drugs for PreventionDraft10/17/2024
User FeesRequests for Reconsideration at the Division Level Under GDUFAFinal10/16/2024
CompoundingTemporary Policies for Compounding Certain Parenteral Drug ProductsFinal10/11/2024
Administrative / ProceduralElectronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and AnswersFinal10/1/2024
Clinical - MedicalConducting Clinical Trials With Decentralized ElementsFinal9/17/2024
Real World Data / Real World Evidence (RWD/RWE)Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical PracticeDraft9/17/2024
Electronic SubmissionsProviding Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for IndustryFinal9/11/2024
Generic DrugsANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFAFinal9/11/2024
Current Good Manufacturing Practice (CGMP), Pharmaceutical QualityControl of Nitrosamine Impurities in Human DrugsFinal9/5/2024
ICH - MultidisciplinaryM12 Drug Interaction Studies: Questions and AnswersFinal8/2/2024
Electronic SubmissionsProviding Over-the-Counter Monograph Submissions in Electronic FormatFinal7/25/2024
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 ProductsFinal7/25/2024
BiologicsPostapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and AnswersDraft7/23/2024
Clinical - MedicalPediatric Inflammatory Bowel Disease: Developing Drugs for TreatmentDraft7/19/2024
Clinical - PharmacologyClinical Pharmacology Considerations for Human Radiolabeled Mass Balance StudiesFinal7/18/2024
Clinical - PharmacologyDrugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older Guidance for IndustryFinal7/15/2024
Combination ProductsPurpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination ProductsDraft7/08/2024
ICH - MultidisciplinaryM14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of MedicinesDraft7/05/2024
BiosimilarsConsiderations in Demonstrating Interchangeability With a Reference Product: UpdateDraft6/21/2024
Generic DrugsFacility Readiness: Goal Date Decisions Under GDUFAFinal6/18/2024
Clinical/AntimicrobialDiabetic Foot Infections: Developing Drugs for TreatmentFinal6/17/2024
Clinical - MedicalClinical Pharmacology Considerations for the Development of Oligonucleotide TherapeuticsFinal6/14/2024
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