Federal Register notice: CBER requests information from stakeholders about critical scientific challenges and opportunities to advance individualized ...
FDA warns Tempe, AZ-based PureChemPros it is illegally manufacturing and distributing unapproved and misbranded new drugs that violate CGMP regulation...
Federal Register notice: FDA releases its FDA Information Technology Strategy, which is open for comments until 10/30.
FDA grants InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as an adjunctive thera...
Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software.
FDA warns Miramar, FL-based Kimera Labs about illegally manufacturing and distributing unapproved exosome products that have CGMP deviations.
FDA publishes a draft CDRH strategic plan for medical device international harmonization.
Three Ropes & Gray attorneys analyze three FDA draft guidances intended to modernize the 510(k) program, saying they are likely to be precursors to fu...
