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GDUFA: How Much Does FDA Know About U.S. Generic Market After Facility Self-Identification?

This article was originally published in The Gold Sheet

Executive Summary

FDA continues to analyze facility data following generic drug facility fee announcement; some fees were higher than anticipated after fewer manufacturing plants registered than expected. But industry believes the count is accurate and illustrates the influence of foreign manufacturers.

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US FDA Changes Data Source For GDUFA II Facility Fee Setting

Agency primarily uses application data instead of facility self-identification lists to determine FY 2018 generic drug user fees.

US FDA Changes Data Source For GDUFA II Facility Fee Setting

Agency primarily uses application data instead of facility self-identification lists to determine FY 2018 generic drug user fees.

GDUFA Self-Identification Woes Can’t Deflate Industry, FDA Enthusiasm

As the grace period nears its close, industry officials say they expected problems getting generic drug manufacturing facilities to self-identify under the new user fee requirement; meanwhile, FDA expects to hire nearly three times the staff in the Office of Generic Drugs to meet GDUFA commitments.

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