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Impact at the FDA from the Government Shutdown

The impact at the FDA from the government shut, as well as the potential impact to the public, has been running relatively below the radar.  Everyone relies on the FDA for safe medicines, food, and animal products.   If the FDA is feeling the effects from shutdown, so could the public.  In the wake of this lingering shutdown, FDA has been forced to begin to assess its options in order to focus resources on key consumer protection functions.  The longer the government shutdown continues, the greater the potential harm to public health.  Here are some points to consider:

Currently,

  • FDA cannot accept any new drug, biologic, device, or generic applications that require payment of user fees until the shutdown ends.
  • FDA cannot accept any new INDs for review (aside from emergency INDs).
  • User fees and carryover funding could run out within weeks.

 

Potential far-reaching results:

  • Delayed approvals of life-saving drugs.
  • Delayed generic approvals, affecting costs.
  • Lower workforce morale potentially causing a mass talent exodus from the agency.
  • FDA’s ability to recruit and retain staff being severely impaired.

 

To read the complete article, please follow link:  https://bit.ly/2VXLZVP

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About James F. Lynch

Dr. Lynch founded his first recruiting firm, Strategic Access Inc. (SAI), in 1998 with over 17 years of experience within the pharmaceutical industry in business development, new product & market development, strategic alliances, operations & administration. In 2000, Dr. Lynch joined Reliant Pharmaceuticals as a founding member and Executive Director of Business Development, subsequently forming Commercial Operations as Vice President. Dr. Lynch returned to SAI in 2004 to assume the role of President, and in 2014 acquired Regional Personnel.

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