FDA Draft Guidance Tackles Quality-Related Controlled Correspondence

The FDA is responding to frequently asked questions from sponsors of generic drugs on quality-related control correspondence with the agency in a new draft guidance.

The Office of Pharmaceutical Quality (OPQ), which reviews submissions from generics developers that request information regarding chemistry, manufacturing and controls, as well as product quality microbiology, said it hopes the nine-question guidance will help reduce the amount of correspondences it must evaluate.

Most of the questions in the draft guidance address specific details. For example, if a reference listed drug (RLD) is a sterile injectable packaged in a small sealed vial, does the proposed generic need to have the same container system? The OPQ says no.

Another question posed is how many exhibit batches used for review should be provided for each manufacturing site if a sponsor plans to include more than one facility in an abbreviated new drug application (ANDA).

The OPQ says stability data from at least three exhibit batches from each plant, for each dosage strength, should be submitted in the ANDA.