The Food and Drug Administration today is scheduled to publish a Draft Guidance in the Federal Register entitled Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and DRug Administration Staff: Public Availability of Advisory … Continue reading
There are 65 days left to the Iowa Caucus. As I mentioned last week, I intend to profile the healthcare positions of each of the candidates as those positions might affect the workings of the FDA and the pharmaceutical market. … Continue reading
Tomorrow, the FDA will be publishing a Notice entitled the "User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biologic Products; Request for Notification of Participation and nUmber of Advertisements for Review" – A MOUTHFUL! … Continue reading
In July of 2000, two companies tried to take statins from RX to OTC. The first was Bristol Myers Squibb attempting to switch Pravachol and the other was Merck trying to switch Mevacor. Today, there is a Federal Register notice … Continue reading
Since 2000, more than 7 million Americans have entered the ranks of the uninsured. Today, healthcare, and its related elements, are the number two concern among voters. We have no shortage of candidates, though the ranks grew smaller last week … Continue reading
