Tag: 监管审批

Submission publishing for investigational drug programs can be prohibitive and costly as health agencies require ever more submission types in electronic formats like eCTD (electronic common technical document). Rapidly changing regulatory requirements and mandates across markets makes maintaining compliance increasingly difficult. The volume of the documentation can vary significantly and be quite an undertaking for … Continued

In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting medical devices. This guideline was published and went into immediate effect without a transition … Continued

 2021 年 8 月 25 日 at 2:00 p.m. ET The U.S. FDA offers four distinct programs to speed the development and availability of drugs that address an unmet medical need in the treatment of a serious or life-threatening conditions: Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Additionally, other programs, such as the Regenerative Medicine Advanced … Continued