Remember when you only had to call to OGD to get ANDA statuses? Remember when these was a chemistry contact, a bioequivalence contact, a labeling contact, and a micro contact? Well, now, not only do you have to try to figure out who your contact is, but what you can all them about. The regulatory Project Manager in the Office of Generic Drugs is your primary point of contact for your ANDA. But now you also need to know who your “Quality” contact is in the Office of Pharmaceutical Quality’s (OPQ) Office of Programs and Regulatory Operations (OPRO). In addition, you need to learn a whole bunch of new acronyms!
So, in addition to OPQ and OPRO defined above, you had better know who your RBPM (Regulatory Business Process Manager) is! The RBPM is responsible for the centralized project management of the quality assessments for applications. And while you are not supposed to call them to find out status of the quality assessments of your ANDA, you may need to contact them to assure your new information requests (IR) and easily correctable deficiency (ECD) responses are appropriately labeled when submitted. They will be your primary contact for this function and in responding to IRs and ECDs.
Yes, you read correctly. The quality assessments will now incorporate IRs (like in New Drugs) as well as ECD correspondence. The new paradigm as outlined by OGD and it is designed to significantly reduce the number of review cycles to hopefully enable a first or second cycle approval.
The new quality assessment paradigm will require you to know the appropriate codes to place on your response and, remember, provide only responses to the IR and ECD that are requested. Submission of additional information beyond that requested will likely cause a delay in the review of your submission and might send it into a tiered amendment classification.
Thus starts a new learning curve for the industry in how to deal with OGD, who to call and what questions you can ask of whom!