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Biotech, Device, and Pharmaceutical Companies

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CBR News Briefing About the FDA Shutdown:

On December 21, 2018, funding for United States federal government services lapsed (“shut down”) because the Congress and President did not pass an appropriations bill for the 2019 fiscal year. Until a new appropriations bill or continuing resolution is passed, non-essential services provided by the federal government, including some functions provided by the FDA, will be unavailable. FDA will continue to perform activities necessary to address imminent threats to human health during this period, including:

“monitoring for and quickly responding to outbreaks related to foodborne illness and the flu, supporting high-risk food and medical product recalls when products endanger consumers and patients, pursuing civil investigations when we believe public health is imminently at risk and pursuing criminal investigations, screening the food and medical products that are imported to the U.S. to protect consumers and patients from harmful products, and addressing other critical public health issues that involve imminent threats to the safety of human life. Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue.”
-- FDA 2018 Lapse in Funding Information

In addition, FDA programs funded by user fees carried over from the previous fiscal year will continue until such funds are exhausted. This may include review of previously submitted original IND, NDA, and BLA applications. The FDA’s Electronic Submissions Gateway remains active and is able to accept many submission types, including original INDs, IND amendments, and NDA/BLA supplements. Note that no estimated date has been published for when carried over user fees will be exhausted, requiring cessation of these activities. The FDA is not able to accept submissions that require payment of a user fee (including biosimilar applications, original NDAs, and original BLAs) and will not be able to accept such submissions until an appropriations bill is passed.

While some FDA operations are continuing, approximately 40% of their workforce has been furloughed (click here for more information about this). Consequently, Agency response times are expected to be longer than normal for topics that do not involve an imminent risk to human health. New requests for meetings with the Agency are unlikely to be granted until the lapse period ends, and the timeline for conducting previously granted meetings is in doubt. Nevertheless, Sponsors are required to comply with established regulatory timelines for certain submissions (such as SUSAR reports, 120 day safety updates, annual IND/NDA/BLA reports/etc.).

If you would like to know more about this, feel free to contact CBR at 720-746-1190 or info@cbrintl.com.


What We Do

We provide expert services in the following areas:

  • US & EU Regulatory Representation
  • Biotech Product Development
  • Process & Methods Validation
  • Nonclinical Development Programs
  • cGMP Training & Certification
  • RealTime™ Clinical Trial Oversight
  • Vaccine Development
  • Device & Combination Products

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