by Naveen kumar | Sep 19, 2024
The Sakigake Designation is an innovative program by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), designed to fast-track the development and approval of breakthrough medical products. “Sakigake” translates to “forerunner” or...
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 4, 2024
In this article, you are going to learn about the regulatory procedure for combination products in the US. What is RFD what are the timelines for it and what role of the Office of Combination products? Combination products as discussed in the article are medicinal...
