FDA Articles

Having published the bar-code rule as a major initiative in the fight against medication errors, the Food & Drug Administration is not resting o­n its laurels. The agency is working o­n a series of guidance documents and proposed rules that, when finalized, will provide more detailed adverse drug reaction (ADR) reports to the FDA's MedWatch system and allow the agency to provide pharmacists and clinicians with faster, better information. In fact, a number of speakers at a session called Patient Safety-Risk Assessment and Management of Medical Errors and Adverse Events at the FDA's Annual Science Forum last month emphasized the agency's growing focus o­n risk communication. FDA officials see that as a two-way street.

You survived the FDA inspection. Now what? FDA always finishes the inspection by leaving you with a list of its observations. Part 3 concludes the survival guide series by describing the steps every company should take after the inspectors leave — from developing a corrective action plan to writing a detailed response document.

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Pharmaceutical & Medical Packaging News
July 1999

Pharmaceutical Representative, Jul 1, 2002

John E. Snyder, John Snyder & Company, Inc.Journal of Validation Technology, May 2003 • Volume 9, Number 3

It's been a tough season for drug safety: FDA's long-awaited analysis of antidepressant use in children found that there were indeed safety issues; o­ne of the world's best-selling drugs was pulled from the market; and the United States lost half of its flu vaccine supply when a plant was shut down over manufacturing concerns.

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David Filmore
Modern Drug Discovery, July 2004

By Charlie Hoppes, Carol Holquist, and Jerry Phillips A 19-year-old patient who ordinarily takes olanzapine is given 250 mg of clozapine in error. He begins to show signs of neuroleptic malignant syndrome and his blood pressure drops to 84/ 27mm Hg. What happened? The generic, or nonproprietary, names for the products were confused. The way drug products are given their generic names may have helped cause the confusion. The Food & Drug Administration requires that either the established (official) name or, in the absence of an official name, the common or usual name appears o­n labels and labeling of a drug product. This name, loosely referred to as the generic name, must accompany the proprietary (brand) name if there is o­ne.



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An FDA Warning Letter can be a business disaster. This case study tracks a company from receipt of an FD 483 — that did not find contamination, but o­nly the potential for contamination — to 18 months later when the facility received a clean bill of health. What it did to get there — and what it learned — may keep your site from losing its operating freedom.

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Todd Zwillich
Drug Topics, Jul 12, 2004