The QMN Weekly Bulletin

All drugmakers need a social media policy regardless of whether they have an active presence in the online world or not, experts at the Food and Drug Law Institute’s annual conference advise.

Endotec was left holding a Form 483 after FDA investigators found shortcomings with the orthopedic devicemaker’s procedures for validating and revalidating medical implants.

Simply translating a medical device’s instructions for use (IFU) from the original language into Chinese will likely land foreign devicemakers in the regulatory hot seat, according to Vic Zhang, director of regulatory affairs-China for Smith & Nephew’s Advanced Surgical Devices Division.

Watson Pharmaceutical’s purchase of Actavis firmly positions it as one of the top generic-drug makers in the world, giving it access to Asian and European markets it didn’t have before.

The increased use of automated control systems for cut labeling can reduce the risk of human error during the packaging process, the FDA says in a regulatory tweak that allows drugmakers greater flexibility in meeting manufacturing requirements.

The FDA would be required to implement a unique device identification (UDI) system by the end of 2013 if a new Senate bill becomes law.

Hospira is recalling one lot of its morphine sulfate injection after finding manufacturing irregularities.

The FDA has warned Octapharma over journal ads for its Octagam injection for immune system disorders, as the ads lack risk information and misbrand the product.