The QMN Weekly Bulletin

A report of an exposed conductor in a St. Jude defibrillator lead has renewed questions about the safety of some of the company’s cardiac products.

Amid ongoing efforts to address a previous FDA warning, Impax Laboratories has been hit with a fresh Form 483 after a general inspection unearthed additional quality issues at the company’s Hayward, Calif., facility, further complicating a growing ANDA backlog, the drugmaker says.

Allowing physician-owned entities to purchase surgical implants lowers costs and improves pricing transparency if done correctly, a legal expert maintains.

After a warning letter and two failed inspections, the FDA called in the big guns, requesting that U.S. marshals seize an unapproved, misbranded scar removal drug marketed by Crescendo Therapeutics.

Citing particulate and specification concerns, Teva is voluntarily recalling tens of thousands of bottles of generic hypertension drugs and five lots of generic oral contraceptives, the FDA says.

An FDA inspection of Salt Lake City-based BioMeridian International found 16 observations — most in the form of missing procedures or documentation.

A dishonest and insubordinate study coordinator has compromised a clinical trial, endangered subjects and led the site’s clinical investigator to discontinue conducting clinical research, according to an FDA warning letter.

Succinct, simply worded standard operating procedures (SOPs) that can be expressed in cartoon or flowchart format lead to higher rates of compliance, pharma experts say.