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April 27, 2012

Vol. 4 No. 17

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All Drugmakers Must Develop Social Media Policies, Monitor Internet for Chatter About Products, Experts Say

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. Read More

Endotec Gets 483 for Sterilization, Validation Shortcomings

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

Navigating China’s Labeling, Ad Regulations: An Expert’s Guide

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. Read More

Watson Creates Third-Largest Generic-Drug Company With Actavis Buy

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. Read More

FDA Rule Tweak Touts Use of Automated Systems for Cut Labeling

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. Read More

Senate Bill Would Boost Flow of Device Supply Chain Data

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. Read More

Hospira Recalls One Painkiller Lot After Manufacturing Mishaps

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

Octapharma Warned on Journal Advertising for Immune System Drug

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. Read More