Category: FDA Drug Safety Oversight
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FDA Advisory Panel Wants To Review Agency’s Drug-safety Monitoring Efforts
Concern Over FDA’s Handling of Serious Side Effects Issues, Including Recent Drug Recalls Involving Vioxx and Bextra Members of an FDA advisory panel have voted unanimously in favor of having the federal agency provide…
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FDA’s Adverse Event Reporting System (AERS) Needs Improvement
Reports of Potential Drug Side Effects by Physicians, Pharmacists, Patients, and Manufacturers The Adverse Event Reporting System, or AERS, is the FDA’s system to monitor potential side effects of a prescription drug after it…
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Medicare to Aid FDA by Creation of Drug-safey Database
Serious Side Effects and Other Safety Issues Would be Discovered Sooner In an effort to reduce delay in the issuance of FDA safety recalls of drugs, Medicare wants to create a massive electronic database…
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New “Drug Watch” Web Page for Drug-safety Information
Emerging Drug-safety Issues Will be Posted on New FDA Site Late last week the FDA announced guidelines for its proposed "Drug Watch" web site, which would be aimed at letting patients know about emerging…
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Drug-safety Information Database Project by UnitedHealth Group
Serious Side Effects Monitoring of New Medications Should Improve UnitedHealth Care Inc., one of the nation’s largest health maintenance organizations in the U.S., has announced a new drug-safety monitoring tool which should provide more…
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Grassley-Dodd Bill Would Allow FDA to Order Immediate Drug Recall or Increased-Risk Warning
FDA Would No Longer Have to Negotiate Safety with Drug Manufacturers Unfortunately it took more than a year for the US FDA and Merck & Co. to agree on labeling changes for the now…