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Citizen Petitions Targeting ANDAs Recede, But Concerns Over Resources Remain

 
• By Michael Cipriano

FDA worries about diverting resources to respond to 505(q) petitions, despite receiving lowest number in fiscal year 2015 since it began tracking requests.

FDA received only 15 petitions seeking to delay approval of competing products in fiscal year 2015, tied for the lowest amount over the past eight fiscal years. But that did not stop the agency from sounding off to Congress about having to divert resources from public health issues to attempts from sponsors to delay generic competition.

According to the agency's eighth annual report to Congress on delays in approvals of applications related to citizen...

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