FDA Articles

Pharmaceutical & Medical Packaging News
November 2000

Pharmaceutical & Medical Packaging News
February 2000

Jill Weschler
Applied Clinical Trials, Mar 1, 2004

To improve FDA's ability to respond to terrorist attacks, acting commissioner Bernard Schwetz tapped Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), to establish a formal crisis management program for the agency. Woodcock moved to the commissioner's office in November to develop a program to better track and coordinate FDA responses to terrorism. She willcoordinate FDA actions with those of other government agencies develop contingency plans in case FDA becomes incapacitated prepare a long-range counter-terrorism program as part of FDA's permanent crisis management effort.

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Applied Clinical Trials, Aug 1, 2002

Pharmacists and toxicologists applauded the recent decision by a Food & Drug Administration advisory review panel to require clear warnings about the risk of liver damage stemming from acetaminophen. The panel's recommendation came as no surprise to Rick Kingston, Pharm.D., senior clinical toxicologist, Prosar International Poison Center, St. Paul, and associate professor, department of experimental and clinical pharmacology, College of Pharmacy, University of Minnesota. "It's not uncommon for patients to use multiple products with acetaminophen [APAP] and not really know they are getting acetaminophen in excessive quantities, which can lead to serious complications," he said. "We also know acetaminophen is handled differently by some populations in terms of the way they metabolize it and break it down."



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Drug Topics, May 3, 2004

FDA and manufacturers seek to curb bogus drugs, while legislators consider liberalizing import policies to cut pharmaceutical costs.

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Drug Topics, Jan 24, 2005