regulatory affairs strategy

The Affordable Care Act’ (ACA) ride through legislative and judicial hurdles has focused on the high profile aspects of the law including the insurance mandate and state Medicaid responsibilities.  However, one part of the law that will have a major impact on...

Many small pharmaceutical companies and biotech manufacturers continue to struggle with FDA approval delays that have developed over the past several years. Even internationally, regulatory guidelines have evolved to the point of being outright onerous in some...

More regulations, more problems. It’s not exactly a catchphrase yet, but it is something you might have overheard within a pharmaceutical regulatory affairs office over the past several years. The simple fact is that over the past five to ten years, guidances...

Compliance is a necessary part of doing business (very necessary for bio/pharm), but sometimes it goes a shade too far. When asked what single factor he would change about compliance efforts at his company if he could, a compliance executive from a top pharma company...

By Ryan McGuire, Senior Research Analyst If you received a memo recently from your compliance group detailing a new standard operating procedure, then chances are your company is using increasingly outmoded training tools. Online compliance training...

By Casey Ferrell, Senior Research Analyst In sports, payroll tends to have a big impact on the quality of a roster. Though it doesn't always equate to Stanley Cups or World Series rings, the rule is pretty simple: more money equals better players equals...

By Casey Ferrell,Research Analyst The ePharma Summit 2012 kicked off with a full day of symposia on three tracks. I attended the Medical, Legal and Regulatory Policy Summit, and as I write this, my head is swimming with interesting facts, perspectives...

Gone are the days when companies could use a healthcare provider's annual salary to calculate fair-market value (FMV) for their consulting services, according to the latest findings from our ongoing key opinion leader compensation research. The precision that...

By Michelle Vitko,Research Analyst The earlier pharmaceutical companies begin mapping out their portfolio management options, the more strategies will be available to them and the more success they will have in general. In fact, a senior director at a...

By Jeremy Spivey,Senior Research Analyst The Prescription Drug Cost Reduction Act, a bill introduced by Sen. Herb Kohl on October 13th, seeks to impose a number of new measures to reduce the US government's budget outlay on pharmaceutical and biotechnology...