An important component of the Advisory Committee meeting is the open public hearing (OPH), normally a one-hour session reserved for the public to share opinions about and experiences with the product. The OPH can last as long as, or longer than, the sponsor or FDA presentations during an Advisory Committee meeting, yet there is little research on any potential impact it may have on the voting. This article originally appeared in Regulatory Focus in September 2015 and discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting.
Achieving authenticity is a journey of self-discovery. Values form the basis for all leadership communication. Once those values are discovered, a leader can begin to communicate through them, not merely about them. Speaking through values inspires leaders and gives them the ability to inspire others. Audiences know authenticity when they see and hear it. These three principles can help put you on the road to authenticity.
Prescription drug pricing has become a very hot topic in the last year. To have a better and more productive policy debate about drug pricing, we need to have a better understanding of how the market landscape—and the market risks—have shifted for the branded biopharmaceutical business in recent years. What follows is a brief analysis of changes in the U.S. health care marketplace and how they may affect drug launch prices.
Technology was supposed to make our lives easier, but instead of being swamped by paper, many of us are swamped by emails. The result is the same – we can’t find important contact information, individual documents, or entire files. So how can you make sure you are managing your emails instead of having your emails manage you? Here are a few Outlook tips that can be applied to other email providers as well.