by Dr. Yashashwini Reddy | Jun 25, 2024
An abbreviated new drug application is submitted to the FDA Office of Generic Drugs. let us learn about generic drug products before the ANDA application Process. A Generic drug product is comparable to the innovator in terms of strength, dosage form, route of...
by Dr. Yashashwini Reddy | 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 Dr. Yashashwini Reddy | Jun 6, 2024
The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...
by Dr. Yashashwini Reddy | Jun 5, 2024
In this article, you are going to learn about the marketing authorization process in the EU region. European Medicines Agency (EMA) is the key regulator for regulating and monitoring medicinal products in the European Union. It has some expert committees which provide...
by Dr. Yashashwini Reddy | 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...
