Category Archives: Drug Safety

Foreign Suppliers of Pharma Products

On Sunday, two of the nation’s leading papers, the New York Times and the Washington Post both carried front page articles relating to the safety of medical products or components of medical products from China.  The Times article, "FDA Tracked … Continue reading

Posted in Drug Safety | Comments Off

The Congressional Hearing on Avandia

I attended the House Committee on Government Oversight and Government Reform hearing on the GlaxoSmithKline diabetes drug Avandia yesterday.  It was crowded and heated, both literally and figuratively.  If you are interested in watching the video of the Avandia hearing, … Continue reading

Posted in Drug Safety | Comments Off

Risk Management Committee Announced; Congressional Hearing Tomorrow

Yesterday the FDA announced the formation of the Risk Communication Advisory Committee – a new 15 member committee solely dedicated to help FDA better understand the communication needs and priorities of the general public; advise FDA on the development of … Continue reading

Posted in Drug Safety | 5 Comments

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

Compare and Contrast – EMEA and FDA on Avandia

The FDA issued a press release on the issuance of a safety alert on Avandia  on May 21.  On May 23, the European Medicines Agency (EMEA) also released a statement on Avandia safety.  I thought it interesting to compare the … Continue reading

Posted in Drug Safety, FDA Image | 2 Comments