Your Rights If FDA Agreed To Your Proposed Q1/Q2 ANDA Formulation But Sends A Refuse to Receive (RTR) Instead?
The pharmaceutical industry is complex and expensive. Companies and investors deserve certainty. Imagine asking an agency what to do, the agency tells you to do X, you invest time/effort/resources into doing X, and when you file the drug application on X, the agency says “oops, it’s not-X”. The applicant is ambushed and doesn’t know why […]
