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- 05/16/2017

Fda inspectors will focus on specific product areas

Pharma Horizon

Scott Gottlieb, new Food and Drug Administration commissioner, has decided that the Federal inspectors will begin specializing in specific product areas rather than activities in their U.S. geographic regions.

 

The refocusing “will make our field programs more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work,” Gottlieb said in a memo. “We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have.”

Attention on FDA’s oversight has increased as companies produce more complex and powerful drugs and devices, and challenges to food safety mount. The agency doesn’t plan

From now on, due to this reorganization, the 20 district offices Regulatory Affairs instead of report to five region heads, will report to six product-specific offices focused on:

  • pharmaceutical quality
  • medical devices
  • tobacco
  • food
  • biologic drugs, which are made from living organisms and include vaccines
  • research, including protecting research subjects and assuring data quality

The 13 labs swill become more focused on specific challenges focusing on either food or medical products, tobacco and specialty, wheras the 

employees who work on imported products will continue to oversee all types of FDA-regulated goods, 

 

There will be no reductions in employee numbers related to the reorganisation

 

Source: Bloomberg




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