by Dr. Yashashwini Reddy | Jul 2, 2024
What is an Audit trail? In this article, we will learn about what an audit trail is, why it is required, and the contents of an audit trail. An audit trail is a 21 CFR Part 11 compliance requirement. These 21 CFR Part 11 deals with electronic records and electronic...
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 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 Dr. Yashashwini Reddy | 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...
