Posts tagged ‘2012’

PDUFADate.com 2012

As we look back on the last 18 months, we are very pleased with the steady increase in visitors to our website.  We attribute this to the needs of the financial community to seek as many opinions as possible before they make their recommendations or decisions for their clients.  We are pleased that many of you keep coming back to us for help with these decisions.  You are returning because of the high degree of success we’ve had with our opinions on FDA Advisory Committee deliberations and ultimate outcome of FDA actions on pending applications.

Since the initiation of our website, we have had a limited offering of information.  We have provided a short term listing of FDA activities, either Advisory Committee Meetings or PDUFA Dates.  We have provided our opinions on some of these Advisory Committee deliberations and our opinion on some PDUFA Date actions.

As we look forward to 2012, we are evaluating enhancements to the website that we will introduce during the first quarter of 2012.  Some of these include a complete list of the FDA Advisory Committee calender with a link to the Briefing Documents as soon as they become available. In the past, we limited our opinions to those that seemed to have very clear outcomes, even though on several occasions they were contrary to the majority of opinions being expressed.  In some cases, we weren’t sure of the outcome and didn’t provide an opinion.  We have heard from some of our visitors that such a “non-decision” would be valuable for them.  Therefore, in response to your need, we will provide more opinions, some of which may state that we don’t know the outcome.  As in the past, we will provide our rationale.

We are also evaluating the addition of a resource center which will provide a listing of all drugs that we are aware of that are pending approval at the FDA.  Included in this listing will be what we know about actions that may have been taken by regulatory authorities around the world.  We are considering also, a separate listing in the resource center of drugs that are in Phase III development.

From time to time, we may go outside of the boundaries that we’ve established for PDUFADate.com by providing an opinion on broader issues facing the Pharmaceutical Industry.

One of the most exciting additions to the website will be the addition of a Reader’s Forum.  Readers will be provided with an opportunity to ask questions or make comments that can be responded to privately or to the public.