by Naveen kumar | Jun 14, 2024
Global expedited regulatory pathways are processes crafted to speed up new drug approval and availability across different countries. These include drugs, vaccines, and medical devices. These pathways aim to bring the new drugs as fast as possible by fastening the...
by Naveen kumar | Jun 12, 2024
Once we submit the IND application, how the FDA reviews the application and what acknowledgment letter is given after the IND submission all will be discussed here. IND is an application submitted to the FDA to conduct clinical investigations in humans, once the...
by Naveen kumar | Jun 10, 2024
Methods in Pharmacovigilance, this article will give you an overview of the pharmacovigilance methods and the concepts involved in it. Definition of Pharmacovigilance as per WHO: science and activities relating to detecting, assessing, understanding, and preventing...
by Naveen kumar | Jun 10, 2024
Clinical trials are research studies involving human subjects to know the safety, and effectiveness of medical interventions such as drugs, medical devices, biological products, and radiological procedures. People generally volunteer to take part in these studies and...
by Naveen kumar | Jun 8, 2024
A Trial Master File is a collection of documents in an organized way, and it ensures clinical trials are conducted as per good clinical practices following regulatory requirements. TMF is very important in ensuring that the trial has been managed successfully by the...
