Monthly Archives: July 2010

FDA Advances in Social Media – What’s it Mean for Industry?

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

Posted in Uncategorized | 2 Comments

What is PDUFA?

 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 | 2 Comments

New Drug Proposed for FDA Regulation of Cosmetics

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

Posted in Legislation | 1 Comment

Disclosure, Disclosure, Disclosure – Advisory Committee Conflicts of Interest

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

Posted in Uncategorized | Comments Off

PharmaBook – Facebook and Pharma

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

Posted in Uncategorized | 3 Comments