Monthly Archives: October 2006

Global Warming for Generics

Posted on October 24, 2006 by Mark Senak

Lately the environment for generic drugs has grown much warmer. Consider, last week the FDA/CDER proposed a speedier process for considering approval of generics. Walmart, one of the biggest retail chains in the country, announced it would sell many generics … Continue reading →

Posted in Generic Drugs | 2 Comments

More Word on the Adaptive Clinical Trials Workshop

Posted on October 23, 2006 by Mark Senak

PhRMA is staging the Adaptive Clinical Trials Workshop that is being held in November.  This week, a call to PhRMA to ask for more information would be forthcoming has gone unanswered. Still, what I have been able to find out … Continue reading →

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Weekly Roundup – 10/20/06

Posted on October 20, 2006 by Mark Senak

Well, today is Nick and Nora’s first birthday.  They are in every way a blessing, though puppy hood is more work than I remembered. Looking back on the week as it comes to a close, it was an active one.  … Continue reading →

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Counterfits on Counterfeits

Posted on October 19, 2006 by Mark Senak

An incident this week makes me want to echo back to a posting a few weeks ago about counterfeit drugs.  Every time there is a debate about importation someone has a fit claiming that importation is a vector for terrorism … Continue reading →

Posted in FDA Policy | 1 Comment

Waiting for Word on the Adaptive Clinical Trials Workshop

Posted on October 18, 2006 by Mark Senak

Back in July, FDA’s Dr. Scott Gottlieb gave a speech in which he talked about an upcoming conference on clinical trial design to be held in November.  Word has it that the conference is going to be on the 13th … Continue reading →

Posted in Clinical Trials | Comments Off on Waiting for Word on the Adaptive Clinical Trials Workshop