The QMN Weekly Bulletin

A bassinet used to care for newborns in hospitals could pose a risk due to the crib’s wheels, door hinges and drawer slides, the FDA says.

The FDA’s and industry’s PDUFA (Prescription Drug User Fee Act) V Commitment Letter calls for mandatory electronic submission of standardized drug application data in IND applications, NDAs and BLAs.

Virginia devicemaker Eastern Cranial Affiliates, which custom-makes children’s orthotic helmets, received an FDA close out letter following a warning letter from the FDA.

During the past few years, some companies have seen the benefits of creating company core data sheets (CCDS) much earlier in the drug development process.

Inadequate procedures, particularly corrective and preventive action (CAPA) failures, have earned Canada-based Intelligent Hospital Systems (IHS) an FDA warning letter.

APP Pharmaceuticals received a warning letter for persistent media fill failures and recurring critters in manufacturing areas of the company’s Grand Island, N.Y., plant.

Remediation efforts to right manufacturing woes at Hospira’s Rocky Mount, N.C., facility and other plants are expected to cost between $300 and $375 million through 2013, but enough progress has been made at Rocky Mount to presume a return to production within weeks, Hospira CEO Michael Ball says.

American Regent is investigating the root cause behind particles in some retain samples of phenylephrine HCl injection, which prompted a voluntary recall of one product lot.