DRAP Draft Guidance on Clinical Research: Overview
The article provides a general overview of Pakistan’s regulatory requirements for clinical research.
The article provides a general overview of Pakistan’s regulatory requirements for clinical research.
The article highlights the aspects related to studies involving combination products, the ones not initially intended to assess the safety and performance of a medical device, and other specific cases.
The article provides a brief overview of the applicable regulatory requirements related to using real-world data in the context of submissions associated with medical devices intended to be marketed and used in the US.
The new article highlights the aspects related to the existing regulatory pathway, the approach to be applied for different types and classes of medical devices, and the way the intended purpose of the device in question should be considered.
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.