8:28 AM
Jan 09, 2019
 |  BC Extra  |  Politics & Policy

FDA shifting user fees to safety surveillance

As the government enters the nineteenth day of a partial shutdown, FDA is taking steps to focus its dwindling funds on “key consumer protection functions,” FDA Commissioner Scott Gottlieb announced in a tweet.

“One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post market drug safety surveillance,” he said.

He added: “We’re systematically reviewing our portfolio and making sure that our safety functions remain resourced as best they can, for as long as they can. Our consumer protection role is our most critical mission.”

FDA previously announced that it would continue to review NDAs and BLAs that had been submitted prior to Dec. 22, 2018. It is unable to collect new user fees during the shutdown (see "Budget Woes May Linger at FDA").

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