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

 
  • Regulatory NewsRegulatory News

    FDA Wants to Make Some of the Most Dangerous Drugs Less of a Burden on Companies and Physicians

    The US Food and Drug Administration (FDA) soon plans to implement four "priority projects" meant to improve its Risk Evaluation and Mitigation Strategies (REMS) programs—a collection of restrictions meant to protect patients from potentially dangerous drug products. Background REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to act as a regulatory hedge against potentially risky products—the answer to the qu...
  • EMA in Midst of Website Overhaul, Calls for Industry Assistance

    The last decade has seen an increasing shift into digital forms of communication, submission and information in the regulatory affairs space. Sponsors can now submit applications and submit updates to regulators electronically, and-perhaps most importantly-find the regulations and guidance documents they need online instead of in a library or legislative building. But as those layers have built over time, it has become exceedingly difficult for a sponsor to find the exact...
  • GAO Finds FDA Employee Review Practices Lagging

    The Government Accountability Office (GAO), the government agency in charge of auditing federal programs, has reviewed the US Food and Drug Administration's (FDA) and found its employee performance standards to be lagging behind requirements established in federal law. Under the terms of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , FDA is charged with meeting certain deadlines for reviewing pharmaceutical and medical device ...
  • Usability Upgrades Announced for EMA's Website

    The European Medicines Agency (EMA) has announced it has rolled out several usability upgrades for its website, allowing regulatory professionals to access a host of new and customizable features that should be particularly useful in uncovering the latest regulatory intelligence. Some of the new features announced by EMA include RSS feeds for individual medicines, additional filters for its " What's New? " webpage containing all of EMA's latest documents, a rating syst...
  • UK Regulator: Don't Overreact to PIP Scandal

    The head of Britain's Medicines and Healthcare products Regulatory Agency (MHRA), Kent Woods, said modest improvements are necessary to correct deficiencies exposed during the Poly Implant Prothese scandal . In remarks made at a press conference on 16 February, Woods called for "better surveillance and reporting of any problems with medical devices on the market, and more coordination between national medical regulators," wrote Reuters . Woods added that while he t...