相关临床试验
22
10 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
4
18.2%
已完成
8
36.4%
尚未招募
6
27.3%
招募中
4
18.2%
暂无批准数据
- The FDA proposed a rule allowing distributed manufacturing "hub-and-spoke" models to register as a single establishment, reducing administrative burdens and costs. - Foreign establishments manufacturing APIs that indirectly enter the U.S. supply chain would be required to register with the FDA under the proposed rule. - The changes aim to enhance supply chain transparency and give the FDA real-time oversight into where and how drugs are manufactured. - If finalized, the rule is expected to generate long-term efficiencies for both industry and the agency while strengthening domestic pharmaceutical manufacturing.
- FDA officials discussed strategies for integrating artificial intelligence with real-world evidence to advance drug development during a panel at the DIA Global Annual Meeting in Philadelphia. - The number of NDAs and BLAs incorporating RWE increased from four in FY 2023 to ten in FY 2025, while AI-related submissions have surpassed 1,000 across CDER and CBER. - AI excels at pattern recognition, patient identification, phenotyping, and signal detection, but is limited in identifying rare events, according to CDER senior policy advisor Hussein Ezzeldin. - Industry stakeholders have requested practical examples and use cases in response to FDA's January 2025 draft guidance on AI in regulatory decision-making for drugs and biologics.
- The FDA's CDER has accepted a letter of intent for an AI-driven digital liver model under the ISTAND pilot program, marking the first step toward qualification as a Drug Development Tool. - The tool predicts drug-induced liver injury—a leading cause of clinical trial failures—by comparing new small-molecule chemical structures with drugs of known safety profiles. - If fully qualified, drugmakers could use the model in regulatory submissions to improve early safety assessments, reduce reliance on animal testing, and support informed decisions before human trials. - CDER Acting Director Michael Davis stated that emerging technologies show "incredible promise" in streamlining drug development with the ultimate goal of enhancing patient care.
- The FDA published draft guidance on March 9, 2026, establishing formal requirements for drug manufacturers responding to Form 483 inspectional observations for the first time. - The guidance applies to domestic and foreign facilities manufacturing human and animal drugs regulated by CDER, CBER, and CVM, including combination product manufacturers. - FDA recommends an eight-element response format including executive summaries, detailed investigation reports, and comprehensive corrective and preventive action (CAPA) plans with measurable outcomes. - The guidance emphasizes systemic quality system assessments beyond individual observations, requiring companies to identify root causes and broader compliance issues.
