Regulatory Blog

Hi Guys! You have been my supporters and wellwishers from the day I published this website. As you have been supportive of me from day...

Yesterday U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and...

Priority Review indicates that the review process of the application will be expedited by the concerned departments. However, the...

This new pathway supports innovative approaches to the safe, timely, and efficient development of medicines to improve patient access....

This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical...