FDA Worried Citizen Petitions Slowing Drug Approvals


The FDA is worried that abbreviated new drug applications could be slowed by citizen petitions, even though only one such ANDA was delayed by a citizen petition in 2015. The FDA has issued its concerns that the citizen petitions don’t raise valid scientific issues, and are instead used to delay competing drug products. While only one ANDA was delayed in 2015, there were 15 requests by outside stakeholders for the FDA to take action on particular ANDAs. The FDA has said that it must divert resources that could be used to deal with public health concerns to deal with citizens petitions.

Read the source article at RAPS.org

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