Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60...
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Draft Guidance for Industry, IRBs, and Clinical Investigators 2024年4月25日，FDA发布了三份肿瘤临床试验入排标准相关的指南，分别关于“洗脱期和伴随药物”、“活动状态（Performance Status, PS）”和“实验室指标”，为CDER和CBER监管的用于癌症治疗...
The guidance provides recommendations on the following: pathways for use of investigational COVID-19 convalescent plasma patient eligibility collection of COVID-19 convalescent plasma, including donor eligibility and donor qualifications labeling, and record keeping Because COVID-19 convalescent plasma has ...
美国FDA 指导原则 联邦食品、药品和化妆品法工业指南第503A条规定的使用原料药物质配制的临时政策 英文原版.pdf,Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry U.S. D
This guidance recommends that sponsors and applicants not identify submissions that contain RWD/RWE if those data are not intended to support product labeling. For example, submissions using RWD only to generate hypotheses or to plan a clinical trial (e.g., to identify potential trial participants...
I. INTRODUCTION 引言 This guidance helps sponsors of investigational new drug applications (INDs) or applicants of new drug applications (NDAs), abbrev
FDA new guidance on drug labeling and pharmacologic classificationAngie Drakulich
美国FDA 指导原则 阿片类止痛药效益-风险评估的考虑行业框架指南 英文原版.pdf,Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes
General labeling considerations and awareness provided in the guidance include: poor design of product container labels and carton labeling can obscure critical safety information; risk assessments performed during the design stage can reduce the risk of medication errors; ...
SNOMED CT was chosen to harmonize with Indication information in Structured Product Labeling (SPL). Because the granted indication may include important qualifiers to fulfill the need for adequate directions for use (e.g., descriptors of the population to be treated, adjunctive or concomitant therapy...