June 1, 2009
By:Jill Wechsler
Agency officials and sponsors anticipate stiffer oversight of research operations and disclosure requirements.
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June 1, 2009
By:Lisa Henderson
Roundtable participants discuss challenges and successes with early eCTD implementation.
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May 28, 2009
By:Peter O'Donnell
A look into how the European Union is handling the daunting health threats of the swine flu.
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May 11, 2009
Senior Manager of Global Regulatory Affairs for Wyeth discusses the implementation of eCTD and selecting the proper vendor.
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May 11, 2009
Critical comments of the drug evaluation process bring about strong reaction from industry.
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May 1, 2009
By:Jill Wechsler
Government funding slated to boost studies comparing medications to other treatments.
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May 1, 2009
By: Peter O'Donnell
Changing rules on advanced therapy medicinal products to require more from clinical studies.
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April 27, 2009
Shire Pharmaceuticals' Carol Rutkowski explains the benefits of training employees in regard to the regulatory eCTD submissions world.
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