by Naveen kumar | Sep 14, 2024
Differences Between New Drug Application (NDA) and Biological License Application (BLA) The New Drug Application (NDA) and the Biological License Application (BLA) are two critical submissions to the U.S. Food and Drug Administration (FDA), but they cater to different...
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...
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...
