by Naveen kumar | Nov 5, 2024
1. The Indian Patent and Design Act, 1970 Focused on encouraging innovation, this act initially allowed only process patents, enabling Indian companies to produce affordable generic drugs. Over the years, the act evolved, aligning with international standards to...
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 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 2, 2024
In this article, we are going to see the overview of the Purple Book and its contents, and how it helps healthcare professionals, The FDA Purple Book contains the list of approved biological products, and here we are going to see the details of the Purple book, its...
