RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    FDA Launches Pilot to Standardize REMS Information for Easier Systems Integration

    The US Food and Drug Administration (FDA) has announced a four-month pilot to make Risk Evaluation and Mitigation Strategies (REMS) easier to share and integrate with existing pharmacy and health information systems. Background With the passage of the 2007 Food and Drug Administration Amendments Act , FDA was granted the authority to require manufacturers to develop REMS for new and approved products. These plans are intended to enable companies to better manage know...
  • Regulatory NewsRegulatory News

    FDA Releases New Electronic Submission Requirements for Biological Products

    A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) outlines a new process of submitting lot distribution reports (LDRs) in electronic format. Background As required by 21 CFR 600.81 , LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted at least every six months, though FD...
  • Regulatory NewsRegulatory News

    New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes

    US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program. Background The openFDA initiative was born from a May 2013 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public. At th...