June 2012 Posts

As Pharma Cuts Back, CROs Do More

Mark Crawford

Reacting to market and regulatory forces, pharmaceutical science continues to adapt and survive.Years of downsizing and reduced R&D budgets, combined with the “patent cliff” that many large pharmaceutical companies are facing, have resulted in tens of thousands of layoffs, flooding the job market and creating aftershocks felt throughout the industry. Regulatory changes are also hitting hard. New FDA requirements, especially those focusing on long-term studies, have lengthened internal development timelines and increased costs. The overall effects of these changes are reduced drug applications and less innovation, with fewer products in the pipeline. (more…)

Are You Ready for the Medical Device Excise Tax?

Mark Crawford

Most people say it’s really going to hurt—especially for small- to mid-sized medical device manufacturers, possibly even driving them out of business. Companies will likely have to cut jobs and reduce R&D budgets to have enough cash on hand to pay the tax, which goes into effect January 1, 2013. (more…)

Legal Protection Always Beats Liability Exposure

Mark Crawford

James Kolka is an expert in risk assessment, especially international regulatory compliance, which includes both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, and documentation (or lack thereof) that could result in litigation. (more…)