Category Archives: Manufacturing

Congress, FDA Should Consider Tech Solutions for Safer Compounding

By Niels Erik Hansen Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened nearly 700 people in […]
Also posted in compliance, Guest Blog, healthcare, Regulatory, Safety, Technology | Tagged , , , , | Leave a comment

IOM: Curb Fake Meds through Track-and-Trace, but Forget "Counterfeits"

A new report from the Institute of Medicine (IOM) has drawn a lot of attention to the public health dangers of falsified and substandard medicines around the world. The aim is to build support for a range of activities that can limit the spread of fake medicines in the U.S. and help developing nations strengthen […]
Also posted in Anti-counterfeiting, compliance, Events, FDA, R&D, Regulatory, Safety, Strategy, Supply Chain | Tagged , , , , , | Leave a comment

The Sunshine Act: Cloudier Still?

With the recent release of the Patient Protection Sunshine Act (PPSA), the Center for Medicare and Medicaid Services (CMS) has established reporting requirements to ensure that drug manufacturers properly disclose payments to physicians in areas of research, continuing medical education, etc. However a key uncertainty is the issue of state pre-emption. While state and local […]
Also posted in compliance, Legal, Medical Education, Meetings, Regulatory | Tagged , , | 1 Comment

Amid Flu Epidemic a Focus on Vaccine Innovation

Also posted in Biotech, Europe, FDA, R&D, Video | Leave a comment

Pharma 2012 Layoffs

Also posted in Emerging Markets, Europe, Global, Marketing, News, People, R&D, Sales, Strategy, Video | Leave a comment
  • Categories

  • Meta