The QMN Weekly Bulletin

Smiths Medical Medfusion 4000 syringe infusion pumps are being recalled due to a software problem.

Drugmakers worry that the FDA doesn’t plan to conduct an honest review of its new drug review program in an upcoming audit.

An FDA warning letter issued to Hospira’s infusion pump plant in Costa Rica may be emblematic of broader companywide manufacturing issues, analysts say.

Drugmakers’ health economics and outcomes research teams must provide earlier input on clinical trials so the data generated have a better chance of ensuring reimbursement for treatments after approval, according to a new study.

Ben Venue subsidiary Bedford Laboratories is expanding its voluntary recall of chemotherapy drug leucovorin calcium due to crystalline particulates in a small number of vials.

The FDA has warned BioMerieux for several violations related to rework procedures and corrective and preventive actions (CAPA) for its microbial detection systems.

Axara Pharmaceuticals has not justified deviations from process control procedures that resulted in drug products gone astray and equipment cleaning confusion, according to an FDA Form 483.

An FDA inspector’s determination that a single product at Dynatronics’ Ooltewah, Tenn., manufacturing plant fit Class II requirements triggered a 15-count Form 483 at the conclusion of a May 21-23 inspection, company President Kelwyn Cullimore Jr., said.