以下是FDA发布的《计划逐步取消单克隆抗体和其他药物的动物试验要求》(FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs)内容中文翻译,英文原文见文末。 今日,美国食品药品监督管理局(FDA)迈出了具有里程碑意义的一...
32.Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry, June 2015, available at:https://www.fda.gov/media/106369/download. 33.Providing Clinical Evidence of ...
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigat...
7. Electronic Submission Format 电子提交格式7.1 eCTD Specifications eCTD规范For information on how to incorporate datasets into the eCTD, please reference the Guidance to Industry Providing Regulatory Submissions in Electronic Format: Certain Human Pharmaceutical Product Applications and Related Submissions Usin...
The FDA issued the Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders in May 2023. The draft guidance provides many specific recommendations for the following aspects of DCT: DCT design, remote clinical trial ...
New Drug Applications (INDs); dated April 2008 2. Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; dated November 2013 3.Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; dated June 2015 ...
Gingery, D, Accelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials. Pink Sheet. 15. 11. 2023. Merrill, J. Regeneron Oncology Setback Delivered By US FDA Crackdown On Accelerated Approval. Scri...
2. Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; dated November 2013 3.Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; dated June 2015
Phase 1 Trials This phase occurs directly after lab testing. Based on the lab testing, researchers have determined that the drug, device or other treatment may provide a benefit to humans. However, at this point, it has not yet been determined how the drug will affect or react to a human...
In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how the guidance should prompt better-designed oncology trials and greater diversity.