FDA Warns Pfizer About Pediatric Trials of Geodon
On April 9th, the FDA issued a Warning Letter to Pfizer, Inc. concerning its conduct during a clinical trial for one of its prescription drugs…
Read More »On April 9th, the FDA issued a Warning Letter to Pfizer, Inc. concerning its conduct during a clinical trial for one of its prescription drugs…
Read More »In an October 13 letter to the FDA, the well respected consumer advocacy organization Public Citizen, gave a strong endorsement to the FDA Draft Guidance…
Read More »St. Petersburg Reporter Chris Hundley wrote (July 1, 2007) a well-written, balanced and comprehensive (as can get in an article) about Contract Research Organizations (CRO’s). …
Read More »A survey published in the New York Journal of Medicine found that more than a third of experts who oversee clinical trials at both medical…
Read More »Answer: Monitoring postmarketing study commitments. The FDA lacks an effective system for monitoring postmarketing study commitments. See the latest OIG Report, dated June 2006.
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