Industry, FDA Debate Safety & Access Issues Not Included In GDUFA Goals

FDA implemented communication policies under GDUFA that limit sponsors to communicating only with regulatory project managers and restrict queries about the review process until a complete response letter is issued, although the agency unveiled plans to assign target action dates to submissions file...

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Bibliographic Details
Published inInsideHealthPolicy.com's FDA Week Vol. 20; no. 44; pp. 1 - 7
Main Author Beasley, Stephanie
Format Journal Article Trade Publication Article
LanguageEnglish
Published Arlington Inside Washington Publishers 31.10.2014
Subjects
Generic drugs
Pharmaceutical industry
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Summary:FDA implemented communication policies under GDUFA that limit sponsors to communicating only with regulatory project managers and restrict queries about the review process until a complete response letter is issued, although the agency unveiled plans to assign target action dates to submissions filed during the first two years that are not attached to metric goal dates (see FDA Week, Sept. 26).
ISSN:2165-4166