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

 
  • Regulatory NewsRegulatory News

    Researchers Say FDA Should Take More Active Role in Disseminating Drug Safety Warnings

    In addition to approving products and making sure bad ones never make it to market, an indispensable role of healthcare product regulators is warning consumers and healthcare professionals about new risks associated with already-approved healthcare products. The US Food and Drug Administration (FDA) regularly sends out such warnings, generally known as drug safety communications , and as of 27 June 2014 had already issued 12 warnings in 2014—an average of two per ...
  • Regulatory NewsRegulatory News

    FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation

    The US Food and Drug Administration (FDA) has released a new draft guidance document on social media focused on how companies can correct blatant misinformation contained on the Internet and social media channels, long a source of frustration for FDA-regulated companies. Background The issuance of guidance on social media was required by the  Food and Drug Administration Safety and Innovation Act ( FDASIA ) , Section 1121 of which calls for FDA to, by August 20...