FDAデータベースリンク集

FDA査察関係の通知

査察官用マニュアル

【生体内生物学的同等性】7348.001 In Vivo Bioequivalence (PDF - 77KB)
【放射性医薬品】7346.832 Preapproval Inspections (PDF - 700KB)
【承認前検査】7352.002 Unapproved New Drugs (Marketed, Human, Prescription Drugs only) (PDF - 52KB)
【未承認の新薬】7353.001 Postmarketing Adverse Drug Experience (PADE) Reporting Inspections
【医薬品製造検査】7356.002 Drug Manufacturing Inspections (PDF - 524 KB)
【無菌医薬品】7356.002A Sterile Drug Process Inspections (PDF - 292KB)
【包装業者】7356.002B Drug Repackers and Relabelers (PDF - 182KB)
【放射性医薬品】7356.002C Radioactive Drugs (PDF - 180KB)
【医療ガス】7356.002E Compressed Medical Gases (PDF - 239KB)
【医薬品原薬】7356.002F Active Pharmaceutical Ingredients (PDF - 150 KB)
【タンパク質原薬】7356.002M Surveillance Inspections of Protein Drug Substance Manufacturers (PDF - 940KB)
【試験／サンプリング】7356.008 Drug Quality Sampling and Testing - Human Drugs
【フィールドアラート】7356.021 Drug Quality Reporting System (DQRS) (MedWatch Reports) NDA Field Alert Reporting (FARs)
【医薬品サンプル配布】7356.022 Enforcement of the Drug Sample Distribution Requirements of the Prescription Drug Marketing Act (PDMA)
【承認後検査】7356.843 Postapproval Inspections (PDF - 592KB)
【偽薬】7363.001 Fraudulent Drugs (PDF - 68KB)

査察官用ガイド

【用水】High Purity Water Systems (7/93)
【凍結乾燥製剤】Lyophilization of Parenterals (7/93)
【微生物試験】Microbiological Pharmaceutical Quality Control Labs (7/93)
【品質管理】Pharmaceutical Quality Control Labs (7/93)
【洗浄バリデーション】Validation of Cleaning Processes (7/93)
【cGMP】Dosage Form Drug Manufacturers cGMPs (10/93)
【経口固形製剤】Oral Solid Dosage Forms Pre/Post Approval Issues (1/94)
【無菌製剤】Sterile Drug Substance Manufacturers (7/94)
【局所用製剤】Topical Drug Products (7/94)
【懸濁剤】Oral Solutions and Suspensions (8/94)
【CS】Computerized Systems in Drug Establishments (2/83)
【CS】Computerized Systems in Food Processing Industry
【CS】Glossary of Computer Systems Software Development Terminology (8/95)
【バイオ医薬品】Biotechnology Inspection Guide (11/91)
【査察マニュアル】Foreign Pharmaceutical Manufacturers (5/96)

cGMP関係の通知

品質システム

【当局報告】Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry
【当局報告】Report a Problem to the FDA
【コンビネーション製品】Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff
【品質システム】Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
【品質取決め】Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry
【ニトロソアミン】Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry
【逸脱/OOS】Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry
【逸脱/OOS】Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: Guidance for Industry
【使用期限】Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry
【使用期限】Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry
【未承認品目】Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry
【偽薬対応】Counterfeit Medicine
【偽薬対応】Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting: Guidance for Industry
【データインテグリティ】Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry
【CS】Computerized Systems Used in Clinical Investigations: Guidance for Industry
【CSV】General Principles of Software Validation: Guidance for Industry and FDA Staff
【CSV】Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry
【治験薬】Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry
【治験薬】Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry
【MRA】Mutual Recognition Agreements (MRA)

製造管理・工程管理

【クロスコンタミ】Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Guidance for Industry
【PAT】PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance: Guidance for Industry
【無菌製品】Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry
【BSE】CVM GFI #76 Questions and Answers BSE Feed Regulations
【共結晶】Regulatory Classification of Pharmaceutical Co-Crystals
【充填】Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
【再包装】Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities: Guidance for Industry
【承認外工程】Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application: Guidance for Industry
【容器完全性】Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry
【容器完全性】Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers: Guidance for Industry
【容器完全性】Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry
【プロセスバリデーション】Process Validation: General Principles and Practices: Guidance for Industry
【プロセスバリデーション】CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
【プロセスバリデーション】Validation of Procedures for Processing of Human Tissues Intended for Transplantation: Guidance for Industry
【プロセスバリデーション】CPG Sec. 638.100 Process Validation Requirements for Drug Products Subject to Pre-Market Approval
【プロセスバリデーション】Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry

品質管理(QC)

【近赤外】Development and Submission of Near Infrared Analytical Procedures
【元素不純物】Elemental Impurities in Drug Products Guidance for Industry
【残留溶媒】Residual Solvents in Drug Products Marketed in the United States: Guidance for Industry
【エンドトキシン】Pyrogen and Endotoxins Testing: Questions and Answers
【溶出試験】The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP): Guidance for Industry
【分析法バリデーション】Bioanalytical Method Validation Guidance for Industry
【分析法バリデーション】Analytical Procedures and Methods Validation for Drugs and Biologics
【分析法バリデーション】Reviewer Guidance, Validation of Chromatographic Methods
【分析法バリデーション】CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology
【参考品／保存品】Retention Samples

FDA-CMC関係の通知

剤形・成分・原材料

【ナノ材料】Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry
【リポソーム製剤】Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
【吸入製品】Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation: Guidance for Industry
【口腔内崩壊錠】Orally Disintegrating Tablets: Guidance for Industry
【チュアブル錠】Quality Attribute Considerations for Chewable Tablets Guidance for Industry
【微粒子製剤】Size of Beads in Drug Products Labeled for Sprinkle Rev.1: Guidance for Industry
【GE品】Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
【錠剤】Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation
【DDS】Residual Drug in Transdermal and Related Drug Delivery Systems: Guidance for Industry
【特定成分用】Pharmaceutical Components at Risk for Melamine Contamination: Guidance for Industry
【特定成分用】Possible Dioxin/PCB Contamination of Drug and Biological Products
【特定成分用】Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products: Guidance for Industry
【特定成分用】Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality: Guidance for Industry
【特定成分用】Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry

バイオ医薬品

【植物】Botanical Drug Development: Guidance for Industry
【抗体】Bispecific Antibody Development Programs Guidance for Industry
【抗体】Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations
【抗体】Monoclonal Antibodies Used as Reagents in Drug Manufacturing
【免疫原性】Immunogenicity Assessment for Therapeutic Protein Products
【免疫原性】Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection
【免疫原性】Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry

生物学的同等性

【生物学的同等性】Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products
【生物学的同等性】SUPAC-IR Questions and Answers about SUPAC-IR Guidance
【生物学的同等性】SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
【生物学的同等性】SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for Industry
【生物学的同等性】SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry

FDA-CMC薬事関係の通知

NDA・BLA・変更申請

【NDA】NDAs: Impurities in Drug Substances
【NDA/BLA】Format and Content of the Microbiology Section of an Application*: Guidance for Industry
【パラメトリックリリース】Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes: Guidance for Industry
【包装タイプ選択】Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for Industry
【無菌バリデーション】Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry
【変更申請】PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites: Guidance for Industry
【変更申請】Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
【変更申請】Changes to an Approved NDA or ANDA: Guidance for Industry
【変更申請】Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry
【変更申請】Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for Industry
【変更申請】CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
【変更申請】CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports
【変更申請】Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA

DMF・IND・AR

ANDA(GE品)

その他通知

【未承認品目】Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry
【環境評価】Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry
【輸入】Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry
【その他／技術革新】Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry
【その他／紛争解決】Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA
【医療経済】Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Guidance for Industry and Review Staff

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