by Naveen kumar | Jul 9, 2024
Sublingual glands or salivary glands are located on the floor of the mouth underneath the tongue. Drugs with characteristics like rapid onset of action, drugs effective in small doses, poor GI absorption, low molecular weight, and lipid solubility are suitable for...
by Naveen kumar | Jun 15, 2024
Navigating the Premarket Notification (510(k)) Process Premarket notification is a regulatory pathway for getting the FDA’s clearance of medical device marketing in the US. A 510(k) is a premarket submission made to the FDA to provide evidence that the medical...
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 2, 2024
In this article, we are going to see the outline of the combination products and their regulations. so what are combination products – In the US combination products are defined in 21 CFR 3.2(e). and in the EU combination terms are not used instead they use...
by Naveen kumar | Jun 2, 2024
How orphan drug designation is given in Japan In the previous articles we have studied orphan drugs and now we are going to learn about how orphan drug designation is given in Japan, we are going to discuss how and what are the laws guiding orphan drug designation in...
