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FDA Drug Regulations in 2014: A Year in Review

Yesterday Registrar Corp posted a year in review of FDA regulations for the food industry.  Today we’re focusing on the progress FDA made in 2014 in the drug industry.

  • June 30:  A final rule became effective that allows FDA to detain drugs found during facility inspections that the agency believes may be misbranded or adulterated.
  • August 18:  FDA revealed a new API that allows users to explore drug labeling and enforcement statistics.  The API revealed that adverse event reports and recalls related to drugs have substantially increased in the past ten years.
  • October 1:  FDA released a guidance regarding the circumstances that constitute delaying, denying, limiting, or refusing a drug inspection.  The guidance addresses actions that may lead to a drug being deemed adulterated.
  • October 1:  The annual registration period for drug companies began.
  • October 2:  FDA announced the release of a new data dashboard where users can view inspection data from FDA’s various centers.  The dashboard allows users to explore reports and trends in FDA inspections or view inspections by country.
  • November 6:  FDA specified the Data Universal Numbering System (DUNS) as its preferred Unique Facility Identifier (UFI) for drug establishments.
  • November 21:  FDA published three guidance documents for outsourcing facilities: one regarding registration, one regarding fees, and one regarding drug product reporting.

Registrar Corp helps drug companies comply with U.S. FDA regulations.  To learn more about FDA regulations for drug companies or how Registrar Corp can help, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/LiveHelp.

Stay up-to-date on FDA news throughout 2015.  Sign up to receive email updates or follow Registrar Corp on Twitter at @RegistrarCorp.





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