by Naveen kumar | Sep 19, 2024
Japan Regulatory Authorities for Drug Approval: A Comprehensive Overview Navigating the complex landscape of drug approval in Japan requires a keen understanding of its regulatory authorities and processes. Japan’s commitment to ensuring the safety and efficacy...
by Naveen kumar | 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 Naveen kumar | 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 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 | May 6, 2024
If you are attending a regulatory affairs interview, you cannot miss these interview questions in your preparation list, before attending the interview checking the previously asked questions is very crucial, because the interviewer is going to test your knowledge in...
