2021年至2022年2月9日，FDA总计发布百余条指南，以下为更新的83条法规，其中包括草案和终稿，主要涉及医药，临床，真实世界，生物药品标签管理，ANDA以及ICH法规更新等多个方面。
以下为新增指南列表，如需指南原文可至FDA官网或后台回复指南名称获取。
主题 |
指南 |
状态 |
日期 |
Clinical / Medical |
Development of Non-Opioid Analgesics for Acute Pain |
Draft |
02/09/2022 |
COVID-19 |
COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels |
Final |
02/08/2022 |
Clinical Pharmacology |
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry |
Draft |
02/07/2022 |
COVID-19 |
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic |
Final |
02/04/2022 |
Procedural |
FDA’s guidance on uniform national policy (Section 585 of the FD&C Act) |
Final |
02/03/2022 |
Clinical Pharmacology |
Population Pharmacokinetics |
Final |
02/03/2022 |
Clinical / Medical |
Assessment of Pressor Effects of Drugs Guidance for Industry |
Draft |
02/03/2022 |
Labeling |
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format |
Draft |
02/03/2022 |
Procedural |
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs |
Draft |
2/01/2022 |
Generics |
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry |
Draft |
1/25/2022 |
Technical Specifications Document |
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH). |
Final |
1/21/2022 |
Clinical / Medical |
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations |
Draft |
12/22/2021 |
Pharmaceutical Quality / CMC |
Inspection of Injectable Products for Visible Particulates |
Draft |
12/16/2021 |
Generics |
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry |
Draft |
12/10/2021 |
Clinical / Medical |
Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products |
Draft |
12/10/2021 |
ICH - Quality |
Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry |
Final |
12/10/2021 |
Pharmaceutical Quality / Chemistry, Manufacturing, and Controls (CMC) |
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports |
Final |
12/09/2021 |
Clinical / Medical |
|
Final |
12/09/2021 |
Clinical / Medical |
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment |
Draft |
12/09/2021 |
Real-World Data/Real-World Evidence (RWD/RWD) and Clinical/Medical |
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products |
Draft |
12/08/2021 |
Clinical/Medical |
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations |
Draft |
12/07/2021 |
CMC |
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators |
Draft |
12/07/2021 |
Real-World Data/Real-World Evidence (RWD/RWD) and Clinical/Medical |
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products |
Draft |
11/29/2021 |
Procedural |
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry |
Draft |
10/29/2021 |
Procedural |
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide |
Draft |
10/29/2021 |
RWD/RWE |
Data Standards for Drug and Biological Product Submissions Containing Real-World Data |
Draft |
10/21/2021 |
ICH - Quality |
Q13 Continuous Manufacturing of Drug Substances and Drug Products |
Draft |
10/13/2021 |
ICH - Safety |
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals |
Draft |
10/6/2021 |
Compounding |
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry |
Rev. Draft |
10/6/2021 |
Administrative/Procedural |
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling |
Final |
9/30/2021 |
Administrative/Procedural |
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers |
Final |
9/30/2021 |
Administrative/Procedural |
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers |
Final |
9/30/2021 |
ICH-Quality |
Q3B(R) Impurities in New Drug Products (Revision 3) |
Final |
9/29/2021 |
Biologics |
Benefit-Risk Assessment for New Drug and Biological Products |
Draft |
9/29/2021 |
Pharmaceutical Quality/ Microbiology Pharmaceutical Quality/ Manufacturing Standards (CGMP) |
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing |
Draft |
9/29/2021 |
Drug Safety |
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices |
Draft |
9/29/2021 |
Real World Data/Real World Evidence |
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products |
Draft |
9/28/2021 |
Pharmaceutical Quality |
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry |
Draft |
9/20/2021 |
Biosimilars |
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3) |
Draft |
9/17/2021 |
Biosimilars |
Questions and Answers on Biosimilar Development and the BPCI Act |
Final |
9/17/2021 |
ICH - Quality |
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry |
Final |
9/16/2021 |
ICH - Safety |
S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS |
Draft |
9/13/2021 |
Covid-19 |
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry |
Final |
9/8/2021 |
Technical Specifications Document |
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) |
Final |
8/31/2021 |
Covid-19 |
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency |
Rev. Final |
8/30/2021 |
Generics |
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application |
Rev. Draft |
8/20/2021 |
Pharmaceutical Quality - CMC |
Development and Submission of Near Infrared Analytical Procedures |
Final |
8/6/2021 |
Clinical/Medical |
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials |
Final |
8/6/2021 |
Clinical/Antimicrobial |
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry |
Draft |
7/28/2021 |
Pharmaceutical Quality - CMC |
Field Alert Report Submission: Questions and Answers Guidance for Industry |
Final |
7/22/2021 |
Clinical/Medical |
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications |
Draft |
7/1/2021 |
Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Final |
7/1/2021 |
Drug Safety |
Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry |
Draft |
6/25/2021 |
Procedural |
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act |
Final |
6/3/2021 |
Procedural |
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification |
Final |
6/3/2021 |
Procedural |
Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act |
Final |
6/3/2021 |
Labeling |
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers |
Final |
6/3/2021 |
Pharmaceutical Quality - CMC and Labeling |
Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry |
Draft |
6/2/2021 |
Pharmaceutical Quality - CMC |
Bispecific Antibody Development Programs Guidance for Industry |
Final |
5/24/2021 |
ICH-Quality |
ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry |
draft |
5/20/2021 |
Biostatistics |
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Guidance for Industry |
draft |
5/20/2021 |
Generic Drugs |
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry |
draft |
5/19/2021 |
Procedural |
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) |
Draft |
5/19/2021 |
COVID-19 |
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry |
Final |
5/17/2021 |
COVID-19- |
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention |
Final |
5/17/2021 |
ICH- |
M9 Biopharmaceutics Classification System-Based Biowaivers |
Final |
5/11/2021 |
ICH - |
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials |
Final |
5/11/2021 |
ICH |
Q3D(R2) – Guideline for Elemental Impurities-Investigators |
Final |
5/11/2021 |
ICH |
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals |
Final |
5/11/2021 |
ICH |
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry |
Final |
5/11/2021 |
ICH |
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex |
Final |
5/11/2021 |
Pharm / Tox |
S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals |
Final |
5/11/2021 |
Procedural |
Qualified Infectious Disease Product Designation Questions and Answers |
Draft |
5/11/2021 |
Pharm / Tox |
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators |
Draft |
4/26/2021 |
Covid-19 |
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/14/2021 |
Covid-19 |
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry |
Final |
4/5/2021 |
Covid-19 |
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers |
Final |
3/4/2021 |
Covid-19 |
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) |
Final |
1/19/2021 |
Covid-19 |
COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity |
Final |
1/13/2021 |
Administrative / Procedural |
IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators |
Draft |
1/4/2021 |