Category Archives: Proposed Legislation

Taking the F out of FDA….

  Twice with in the past week, the New York Times has carried an article referencing the desire among some to split the Food and Drug Administration into two parts, one that oversees food and one that oversees drugs.  On … Continue reading

Posted in Food, Proposed Legislation | 3 Comments

PDUFA IV

As we all wait anxiously for Congress to do its job and actually produce legislation for signature, and as many FDA employees see their jobs hanging in the balance while awaiting PDUFA IV, some may wonder what it is all … Continue reading

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The Senators, the FDA, the Company and The Access to Medicare Data Act of 2007

This year, Senators Charles Grassley (R-Iowa) and Max Baucus (D-Mont) have been on more of a tear than usual regarding the FDA.  A lot of their focus this year has been on post-marketing surveillance of drugs and devices.  They are … Continue reading

Posted in Drug Safety, Proposed Legislation | 2 Comments

What a Ban on DTC Means for Public Relations

There have been several proposals before Congress which, in one way or another, have the potential to impact the amount of direct-to-consumer advertising (DTC) allowed.   Some would give the FDA authority to restrict such advertising.  Others have called for it … Continue reading

Posted in DTC Advertising, Proposed Legislation | Comments Off

Pharmacogenomics, Personalized Medicine and the Future

A lot of people might think that the term "personalized medicine" means medicine that is tailored and fashioned for your particular needs – a drug made to fit you.  In fact, it is the other way around – it is … Continue reading

Posted in Current Affairs, Proposed Legislation, Tutorial | 1 Comment