CDER's Nasr sees reviewers joining in on audits, MAPP template for CMC reviews.

Office of New Drug Chemistry Director Moheb Nasr, Ph.D., told an ExpertBriefing.org audioconference March 10 that his group will soon be renamed the "Office of New Drug Quality Assessment" and that CMC reviewers will be joining inspectors on plant visits.

In addition, Nasr said the office would devise a template under the CDER Manual of Policies and Procedures (MAPP) to review CMC submissions.

During the one-hour audioconference, Nasr said his office would like to move away from doing "chemistry reviews" and more toward "quality assessments," hence, the name change.

"A chemistry review is done mostly by chemists and data analysis to focus more on chemistry and less on manufacturing," he said. "There's no clear emphasis on what we consider critical versus non-critical. It's not a peer-reviewed process, either."

He also said the current paradigm provides "insufficient dialogue between the CMC reviewer and the applicant, and not just on CMC, but on clinical issues."

But under a "quality assessment," Nasr said FDA hopes to "enhance the review and bring more focus on the critical quality attributes, not just chemistry." He said this includes drug stability, manufacturing processes and product performance.

The key to doing this is the new "Quality Overall Summary" and firms submitting development reports with their applications, along with the creation of a CMC Advisory Committee under the auspices of the Advisory Committee on Pharmaceutical Science. In addition, the 150-person office will undergo new post-marketing evaluation divisions and a manufacturing sciences branch.

He said reviewers will join field staff on inspections, too. "We think this is critical to integrate review functions done by centers and investigators and CSOs [consumer safety officers] in the field."

Nasr gave no timetable on when reviewers would start appearing on plant visits, noting that "we are trying to identify and establish criteria first." He also noted reviewers could arrive after an inspection rather than during.

Asked if the office will ever develop a template for CMC reviews, Nasr said his group is currently identifying a checklist of questions on reviews that "could be in such a MAPP." However, he said FDA is not interested in "replacing a rigid system with a more-rigid system. We want some flexibility in reviews."

Nasr said he did not want to lock in questions for all applications when "we're dealing with a lot of complex dosage forms."

A CD recording of Nasr's one-hour ExpertBriefing on the topic of drug specifications and the pending reorganization of his office is available for $275. To order, email us at [e-mail] or call [phone].