CMO Guidance to Discuss Quality Accord Expectations: FDA Official

The FDA will issue guidance detailing what information drugmakers should share with contract manufacturing organizations (CMO) hired to work on their products, FDA officials say. “Clarification is greatly needed because each agreement is crafted differently and we have to step in when there’s a quality problem,” Kathleen Culver, field investigator and drug preapproval manager with the agency’s Cincinnati District office, said. Culver spoke Sept. 24 at the FDA/Xavier Global Outsourcing Conference.
Washington Drug Letter