Most relevant interview questions for freshers and experienced candidate applying for Regulatory Affairs positions in the US market, specifically in the context of generic submission (ANDAs): For Freshers 1. Can you explain what an ANDA is and its significance in the generic drug approval process? 2. How do you envision your role as…
Today, we are going to share an important lesson from the world of generic pharmaceuticals – the journey of an ANDA (Abbreviated New Drug Application) and what happens when a company encounters a Refuse-to-Receive (RTR) letter from the FDA. The RTR letter serves as a vital communication tool, highlighting specific issues that need attention…
This certification allows generic drug companies to challenge brand-name drug patents before expiration, seeking approval to market their generic version early. They declare the patent invalid, unenforceable, or not infringed. The brand-name manufacturer is notified and can initiate a patent infringement lawsuit within 45 days. If the court rules in favor of the generic company,…
In ANDA submissions, the FDA typically requires stability data for at least 180 days. This data is a part of the chemistry, manufacturing, and controls (CMC) section of the application. The purpose of stability studies is to demonstrate the drug product’s stability over time, ensuring its quality and efficacy throughout its shelf life. This…
The Abbreviated New Drug Application (ANDA) is a crucial regulatory pathway in the United States for the approval of generic drugs. This post provides a detailed overview of the ANDA process, its requirements, and significance in the pharmaceutical industry. 1. Purpose of ANDA ANDA allows pharmaceutical companies to demonstrate that their generic drug product…
