Daily Archives: October 28, 2008

Morningstar on Healthcare Reform

Morningstar health-care analysts offer their take on the candidates’ plans and their possible effects for health-care firms.  

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Warning Letter Summary – Third Quarter 2008, Part 2

The third quarter saw some highly unusual activity on the part of FDA’s DDMAC in terms of both content and quantity.  Addressing the latter first, the FDA issued 8 letters for the quarter, which is a substantial increase for the … Continue reading

Posted in Warning Letters | 1 Comment

FDA Issues Warning Letters to Bayer HealthCare for Marketing Two Unapproved Drugs

Here is a significant movement by FDA and a press release just received: The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women’s Low Dose Aspirin + … Continue reading

Posted in FDA Policy, Warning Letters | 1 Comment