FDA Largely Shutdown

With the Federal Government on shutdown, the FDA is largely shutdown as well. The FDA’s official announcement regarding the shutdown states that in the absence of either a 2014 fiscal year appropriation or an FDA specific Continuing Resolution, the FDA’s activities going forward will be limited to the following;

  • emergency work involving the safety of human life or protection of property;
  • criminal law enforcement work; and
  • activities funded by carryover user fees under certain acts such as the Prescription Drug User Fee Act.

Until an FDA specific appropriation is made or the shutdown ends, the FDA will not be able to accept any regulatory filings that require a fee payment in the 2014 fiscal year. Pharmaceutical and medical device companies are sure to be watching the developments closely as there is little information available about what the shutdown means for regulatory filings already filed, but waiting FDA approval.

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