The US FDA is publishing immediate and modified release QbD examples to help generics companies prepare for full implementation in 2013.
Adoption of question-based review by the US Food and Drug Administration (FDA) moved generics applications towards quality-by-design (QbD). The FDA is now accelerating the QbD push and says it is collaborating with the generics industry to prepare companies for the shift.
“We’re working together to develop examples for immediate release dosage forms, as well as for modified release”, Lawrence Yu, deputy director, science and chemistry at the FDA, told in-PharmaTechnologist. The examples are designed to help generics companies fully adopt QbD.
Manufacturers of generics have until January 2013 to understand and adopt QbD. “As we’ve said many, many times FDA Office of Generic Drugs expects QbD applications starting January 2013. You heard right, full implementation of QbD in January 2013”, Yu said.