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  • CDRH Finalizes Policy Intended to Help Device Industry Reduce Regulatory Uncertainty

    A new standard operating procedure (SOP) unveiled last week by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) establishes how the agency plans to implement and update certain types of guidance documents. Background Guidance documents are commonly used by FDA to indicate its specific interpretation of otherwise vague statutory requirements. While they almost never establish legally enforceable standards (though they can, suc...
  • New IMDRF Document Explains How an Idea Becomes International Regulatory Guidance

    Nearly one year after the International Medical Device Regulators Forum (IMDRF) replaced the Global Harmonization Task Force (GHTF), the manner in which the new group functions is getting clarity thanks to a finalized standard operating procedures document released this week. Background IMDRF launched in 2012 as the regulators-only successor to the GHTF, which disbanded in December 2012 after its device regulatory members decided to split off and form their own juncture...
  • CDRH Revises Standard Operating Procedures for Dispute Resolution

    The US Food and Drug Administration (FDA) has released an updated standard operating procedure (SOP) aimed at defining the process by which agency staff can resolve differences of opinion between staff regarding the safety or efficacy of a medical device. The SOP, entitled SOP for Resolution of Internal Differences of Opinion in Regulatory Decision-Making , was published by the Center for Devices and Radiological Health (CDRH) on 10 September 2012. The document expl...
  • EMA's Rasi Moves to Streamline Conflict of Interest Policies at EMA

    The European Medicines Agency (EMA) has released an updated procedure governing how the agency's employees are investigated for any potential conflicts of interest (COI) relative to their duties reviewing medicinal products. The standard operating procedure (SOP), Conducting checks for conflicts of interest of Agency employees assigned duties relating to medicinal products for human or veterinary use , was approved by EMA Executive Director Guido Rasi on 23 March 2012...
  • New FDA Standard on Cargo Theft Released

    The US Food and Drug Administration (FDA) released a new standard operating procedure (SOP) for staff outlining how FDA responds to cargo thefts. The 23 March SOP, FDA'S Response to Cargo Thefts , intends to "provide a general procedure for determining FDA's regulatory response when a cargo theft involving an FDA-regulated product has occurred," writes FDA. "FDA is very concerned about the increase in cargo and warehouse thefts of FDA regulated products, including pres...
  • FDA Seeks to Standardize CDER's Telephone Availability

    A new manual of policies and procedures (MAPP) released by the US Food and Drug Administration's (FDA) Office of Management (OoM) dictates how the Center for Drug Evaluation and Research (CDER) must maintain adequate and consistent phone coverage to allow regulatory professionals and the public to reach the agency during normal business hours. "As Federal employees and public servants, CDER employees must be responsive to the needs of the public," writes OoM. "The public...