OAI (Official Action Indicated) classification: the facility is deemed out of compliance with CGMP. OAI regulatory meeting is conducted if FDA have already issued a warning letter. To DISCUSS THE ISSUES WITH THE FIRM BEFORE PURSUING LEGAL ACTION THROUGH THE DEPARTMENT OF JUSTICE. These meetings provide a deeper dive into technical matters that may require…
What is Regulatory Affairs? Professionals in this field implement regulations from local, state and federal governing bodies to ensure compliance. They also stay up to date on the latest policy changes and recommend new organization protocols as necessary. RA professionals work in Bio pharmaceutical, pharmaceutical and medical devices industries What is Quality Assurance (QA)?…
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…
Ever wondered about the difference between a completely new drug (NDA) 505(b)(1)and a hybrid drug (NDA)505(b)(2)? Let’s explore the contrast between these two pathways! A 505(b)(2) New Drug Application (NDA) is a regulatory pathway in the United States that allows for the submission and approval of certain new drug products. The name “505(b)(2)” comes…
