Federal Register notice: CBER requests information from stakeholders about critical scientific challenges and opportunities to advance individualized ...
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...
Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and W...
FDA says it is converting its medical device Accreditation Scheme for Conformity Assessment from a pilot to a permanent program.
A federal judge sentences Byron A. Marshall of Houston, TX to 300 months in federal prison for his role in leading a counterfeit drug trafficking sche...
Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and W...
