FDA regulatory update

The FDA said that its clinical hold review committee, which reviews the clinical hold orders imposed by the Center for Biologics Evaluation and Research (CBER), will meet in May. The agency invited companies to submit for review the name and number of any investigational biological product trial placed on clinical hold during the past 12 months. The deadline for submissions is April 1.

According to the agency, the committee review is designed to allow a sponsor who does not want a formal reconsideration of clinical hold to have the hold considered "anonymously." In general, FDA said, a product sponsor should consider requesting review when it disagrees with the agency's scientific or procedural basis for the hold.The committee consists of senior managers of CBER, a senior official from the Center for Drug Evaluation and Research, and the FDA chief mediator and ombudsman. ...