CDER’s Quality Super Office Opens for Business

From now on, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle.

The new approach was instituted as CDER officially started operations of its Office of Pharmaceutical Quality, which will oversee all drugmaker quality issues related to manufacturing. Under OPQ, the new risk assessments will identify product and manufacturing risks much earlier in the review process.

CDER has already been using a team approach to reviewing NDAs since October, unofficially through a pilot program. NDAs submitted before that will not be affected by the change.
The goal of the new approach, says CDER Director Janet Woodcock, is for reviewers to conduct a risk assessment to determine which areas of an application contain the most risk to patients and how to mitigate that risk.

The OPQ risk assessment will stay with the product over its life and be used to direct inspections of the manufacturing operations, said Lawrence Yu, deputy director of OPQ. In addition, it will be used during ANDA reviews, when the drug loses exclusivity, so that the same quality controls and risk points are transitioned over to generics manufacturers. Generics companies will also be able to ask the agency minor questions on chemistry, manufacturing and control issues early in the review cycle to speed approvals.

Agency officials did not elaborate on the number of reviewers on each team, but said the team will include the investigator who inspects a company’s manufacturing facility.

As OPQ grows, the office will also be responsible for collecting quality metrics from drugmakers and monitoring quality issues industrywide, but there is no timetable for selecting such metrics.
Woodcock is currently director of the office, which was approved by the White House last fall, and she noted it is still hiring to get up to full staff. She gave no timetable for selecting a permanent director.

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