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Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations
Date:1/14/2014

to develop a PRO instrument for use in medical product development trials. The resulting instrument and a derivative measure, the EXACT-Respiratory Symptoms scale (E-RS), are the first to undergo qualification review by the FDA. These instruments are also under qualification review by the European Medicines Agency (EMA). Evidera maintains copyrights to the EXACT and E-RS in English and all translations (50 to date).

"After years of development and testing, with contributions from a diverse team of scholars, practitioners, industry experts, and patients, the release of this draft guidance represents a major milestone for the EXACT," said Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs for Evidera and Principal Investigator and Director of EXACT-PRO Initiative.  "Furthermore, as the first qualification guidance from the FDA addressing a specific PRO measure, it could well constitute a significant advancement for PROs in drug development."

FDA qualification of drug development tools is designed to expedite the drug development process, in this case, research on the effects of new treatments on exacerbations of COPD. The EXACT draft guidance is the first for a PRO instrument, and follows on the heels of the FDA's release of the final Guidance for Industry and FDA Staff – Qualification Process for Drug Development Tools. The draft qualification guidance document for the EXACT was posted on the Federal Register January 10, with public comments due to the FDA within 90 days.  When finalized, the qualification guidance for the EXACT will represent the FDA's current thinking on the use of this PRO instrument in drug development. 

Chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis, is a progressive lung disease that causes breathle
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SOURCE Evidera
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