- 概要と注目どころ
- 一覧
- CATEGORY – Animal Rule
- CATEGORY – Biosimilars
- CATEGORY – Clinical/Antimicrobial
- CATEGORY – Clinical/Medical
- CATEGORY – Clinical Pharmacology
- CATEGORY – Compounding
- CATEGORY – Drug Development Tools
- CATEGORY – Drug Safety
- CATEGORY – Electronic Submissions
- CATEGORY – Generics
- CATEGORY – Labeling
- CATEGORY – Over-the-Counter Drugs
- CATEGORY – Pharmaceutical Quality CGMP
- CATEGORY – Pharmaceutical Quality/CMC
- CATEGORY – Pharmacology/Toxicology
- CATEGORY – Procedural
- CATEGORY – Real-World Data/Real-World Evidence (RWD/RWE)
概要と注目どころ
FDAのCDER（Center for Drug Evaluation and Research：医薬品の審査を管轄している部局）が、毎年恒例の「今年に公表・改訂予定のガイダンスの一覧」を公表しました。
CDER Guidance Agenda
New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2022 (January 2022)
https://www.fda.gov/media/134778/download
この「予定」は結構いい加減で、ここで予定されているからといって必ずしも公表・改訂されるということはありません（10年以上ドラフト（案）のままのガイダンスもたくさんあります…）。
あくまでFDA CDERの努力目標として受け取った方が良いと考えています。
ただ、FDA CDERが意識している領域、ガイダンスが必要だと考えている領域を知ることができるので、個人的にはアンテナを張っておくべき内容だと考えています。
目を引いたのが、これまでには無かった「Drug Development Tools」というカテゴリーが新設されていたことでした。
今回このカテゴリーに含まれるものは、「Biomarker Qualification: Evidentiary Framework（バイオマーカー認定：エビデンスに基づくフレームワーク）」といった内容のものが1件だけでしたが、最近、FrameworkとかToolとかが多いので、今後増えていきそうです。
一方で、統計関係のガイダンスが一本も無かったのも気になりました。
例年、数本はあったように記憶しているのですが…
下にリストの一覧を掲載しますが、 個人的に注目しているガイダンスにはハイライトを付けています。
特に気になるのは、一番下のカテゴリーであるRWD/RWEに関する2本です。
日本でも議論されている「RWDを外部対照とするデザインと実施に関する考慮事項」と「規制上の意思決定で利用されるRCTにおける臨床データの利用」に関するガイドラインのようです。
とても興味深いです。
RWDに関するガイドラインと言えば、2021年9月にドラフトが公開され、2022年１月までパブコメが募集されていた「Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products」も気になるところです。
こちらはリストにはありませんが、いつ正式に公表されるのでしょう…
一覧
CATEGORY – Animal Rule
- Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
CATEGORY – Biosimilars
- Product Class-Specific Recommendations for Developing Biosimilar and Interchangeable Biological Products
CATEGORY – Clinical/Antimicrobial
- Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases
- Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention
CATEGORY – Clinical/Medical
- Assessment of Pressor Effects of Drugs; Revised Draft
- Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten Free Diet
- Crohn’s Disease: Developing Drugs for Treatment
- Decentralized Clinical Trials
- Development of Non-Opioid Analgesics for Acute Pain
- Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development
- Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
- Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
- Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment
- Protocol Deviations
- Ulcerative Colitis: Developing Drugs for Treatment
- Use of Data Monitoring Committees in Controlled Clinical Trials
CATEGORY – Clinical Pharmacology
- Clinical Pharmacology Considerations for Antibody-Drug Conjugates
- Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
- Clinical Pharmacology Consideration for Human Mass Balance Studies
- Exposure Response Relationships
- General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products
- Pharmacogenomic Data Submission
CATEGORY – Compounding
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised Draft
- Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors – Guidance for Outsourcing Facilities Under Section 503B of the FD&C Act
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
CATEGORY – Drug Development Tools
- Biomarker Qualification: Evidentiary Framework
CATEGORY – Drug Safety
- 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
CATEGORY – Electronic Submissions
- Electronic Submission of Expedited Safety Reports from IND-Exempt BA/BE Studies
- Identification of Medicinal Products: Implementation and Use
- NDC Assignment of Human Drugs including Biological Products
- Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
CATEGORY – Generics
- 180-Day Exclusivity: Questions and Answers; Revised Draft
- ANDA and NDA Submissions: Data Integrity for BA/BE Studies at Testing Sites
- ANDA Submissions – Refuse-to-Receive for DMF Facilities Deficiencies
- ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers
- Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs; Revised Draft
- Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug- Device Combination Product Submitted in an ANDA; Revised Draft
- Content and Format of Composition Tables in NDAs and ANDAs And Corresponding Formulation Labeling
- Evaluation of Therapeutic Equivalence
- Handling and Retention of BA and BE Testing Samples
- Impact of Court Orders on 30 month Stay of Approval
- In Vitro Permeation Tests for Semisolid Topical Products Submitted in ANDAs
- In Vitro Release Tests for Semisolid Topical Products Submitted in ANDAs
- “Open for Business” Definition Under 744B of the Federal Food, Drug and Cosmetic Act
- Pediatric Exclusivity General Considerations for ANDAs
- Physico-Structural (Q3) Characterization of Topical Dermatological Drug Products Submitted in ANDAs
- Revising ANDA Labeling Following Revision of the RLD Labeling
- Sameness Evaluations in an ANDA – Active Ingredients
- Statistical Approaches to Establishing Bioequivalence
- Three-Year Exclusivity Determinations for Drug Products
- Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
- Waivers for pH Adjusters in Drug Products Intended for Parenteral, Otic, and Ophthalmic Use
CATEGORY – Labeling
- Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format; Revised Draft
- Human Prescription Drugs and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers – “Dose Banding”
- Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format
- Labeling for Biosimilar Products (Revision 1)
- Quantification of Sodium, Potassium, and Phosphate in Human Over-the-Counter and Prescription Drug Labeling
- Regulatory Considerations and Drug Labeling Recommendations for Prescription Drug- Use-Related Software for Combination Products
- Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products
CATEGORY – Over-the-Counter Drugs
- Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products
- Formal Dispute Resolution and Consolidated Proceedings: Requestor of OMUFA Products Appeals Above the Division Level
- Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
- OTC Monographs Order Requests (OMORs) – Format and Content of Data Submissions
- Providing Regulatory Submissions in Electronic Format for Over-the-Counter Monograph Requests
CATEGORY – Pharmaceutical Quality CGMP
- PET Drugs – Current Good Manufacturing Practice (CGMP); Revised Draft
- Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross- Contamination
CATEGORY – Pharmaceutical Quality/CMC
- Benefit-Risk Considerations for Product Quality Assessments
- Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
- Quality Considerations for Topical Ophthalmic Drug Products
- Risk Management Plans to Mitigate the Potential for Drug Shortages
- Stability Considerations for Drug Substances and Drug Products in NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products
- Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs
CATEGORY – Pharmacology/Toxicology
- Use of Whole Slide Imaging (WSI) in Nonclinical Toxicology Studies: Questions and Answers
CATEGORY – Procedural
- Charging for Investigational Drugs Under an Investigational New Drug Application – Questions and Answers
- Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements
- Considerations for Rescinding Breakthrough Therapy Designation
- DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescriptions Drugs
- Exclusivity for First Interchangeable Biosimilar Biological Product
- Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers
- Fixed Dose Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of Human Immunodeficiency Virus-1 Under President’s Emergency Plan for AIDS Relief (PEPFAR)
- Identifying Trading Partners under the Drug Supply Chain Security Act; Revised Draft
- Key Information and Facilitating Understanding in Informed Consent for FDA-Regulated Clinical Investigations
- Notifying FDA of Permanent Discontinuance or Interruption in Manufacturing or Drug or Biological Product
- Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft
- Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations; Revised Draft
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug and Cosmetic Act; Revised Draft
- Responding to CGMP Observations on Form FDA 483
- Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Revised Draft
- Tropical Priority Review Vouchers
- Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
- Wholesale Distributor Verification Requirements for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policy
CATEGORY – Real-World Data/Real-World Evidence (RWD/RWE)
- Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
- Using Clinical Practice Data in Randomized Controlled Trials (RCT) for Regulatory Decision-Making for Drug and Biological Products
