Monthly Archives: January 2010

Today the FDA launched what is being billed as the "first phase of its transparency initiative" which is less about transparency than providing a sound educational footing for how the FDA operates.  It is much welcomed, and long overdue.  The … Continue reading →

In the United States, the long-standing culture of direct-to-consumer (DTC) advertising, provides the primary basis by which patients are informed about both conditions and treatments.  It is controversial, with many on either side of the debate finding little middle ground.  … Continue reading →

We are eight days into the New Year.  I don't know about you, but I'm not seeing much different that I like.  Getting back into the grind of things though.  Healthcare reform is behind us.  Now we face the reform … Continue reading →

Two days ago, we examined the number of enforcement actions by DDMAC and yesterday we looked at what tripped regulatory wires to result in a Notice of Violation (NOV) letter.  Today, we're going to look Warning Letters and examine some … Continue reading →

Yesterday there was a quantitative look at the Warning Letters and Notice of Violation (NOV) etters that showed that after years of decline in enforcement, there is no uptick in DDMAC's issuance of these regulatory letters.  Today, the qualitative aspects … Continue reading →