July 27, 2010
Greetings from the 6th Annual PR & Communications ExL Pharma Summit being held in the headquarters of Pfizer in New York, yesterday and today. One of the highlights of the two-day meeting occurred this morning when CDER's head of … Continue reading →
July 26, 2010
I used to have a much beloved co-worker who was not in healthcare, but upon hearing the term "PDUFA" – standing for the Prescription Drug User Fee Act – for the first time during a meeting, shouted out "What the … Continue reading →
Posted in PDUFA, Tutorial
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July 22, 2010
Recently there have been a number of new laws proposed or enacted aimed at giving the FDA more authority over both food and drugs. However, another area (often overlooked) of regulatory authority is cosmetics. This week, however, cosmetics takes on … Continue reading →
July 21, 2010
With real estate of course, it is location, location, location. With government functionaries these days though, the key word is about disclosure. Fierce Biotech carried a nice overview of the recent situation that arose in the wake of the … Continue reading →
July 20, 2010
When social media began to ebb from a media pathway for individuals to connect, to one where institutions and industry began to employ social media as a means of communicating with their constituencies, the pharmaceutical industry, as a highly regulated … Continue reading →