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June 16, 2015
On May 5, 2015, the Food and Drug Administration (FDA) released the final guidance on Providing Regulatory Submissions in electronic format. The guidance implements the electronic submission...
September 2, 2014
In June 2014, the FDA issued two draft social media guidance documents that may not clearly answer all of the questions that the drug and device industries have about how to use social media to...
July 22, 2014
In a blog earlier this month, I mentioned that there are recent initiatives underfoot that FDA hopes will create FDA-industry partnerships, increase transparency, utilize data more effectively, and...
July 9, 2014
In case you haven’t noticed, FDA is tired of being the “bad guy”. While they do not back-off of their responsibility to enforce the applicable Code of Federal Regulations for a millisecond, their...
May 21, 2014
Earlier this year, the Officer of Inspector General (OIG) put smaller life sciences companies on notice that they should put in place a risk assessment process as part of their corporate compliance...
April 23, 2014
Over the past several years, pharmaceutical company Corporate Integrity Agreements (CIAs) have routinely required needs assessments in connection with the engagement of healthcare professionals...
March 12, 2014
At the recent Pharmaceutical Compliance Congress (PCC), Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania stated that one of the key questions that a company should ask about its...
February 5, 2014
A common theme among the government enforcers speaking at last week’s Pharmaceutical Compliance Congress (PCC) was the importance of putting in place an effective corporate compliance program to...
January 29, 2014
One doesn’t have to spend much time in a pharmacy, grocery store or even a typical American house to see that dietary supplements have found a place in people’s lives. In fact, roughly 54% of U.S....