by Naveen kumar | Jun 25, 2024
While learning regulatory affairs there are several abbreviations you come across, you usually end up searching for them. Here is a list of abbreviations that are commonly repeated. There are several topics related to regulatory affairs where you come across these...
by Naveen kumar | Jun 15, 2024
In this article, we are going to see the timelines and regulatory pathways for medical devices, Small molecules drugs, etc. Regulatory pathways for New Chemical entities: Small molecules drugs are chemically synthesized ones i.e. new molecules – Traditional NDA...
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...
