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FDA warns Tempe, AZ-based PureChemPros it is illegally manufacturing and distributing unapproved and misbranded new drugs that vio...[ Price : $8.95]
Federal Register notice: FDA releases its FDA Information Technology Strategy, which is open for comments until 10/30.[ Price : $8.95]
FDA grants InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related...[ Price : $8.95]
FDA warns Miramar, FL-based Kimera Labs about illegally manufacturing and distributing unapproved exosome products that have CGMP ...[ Price : $8.95]
FDA publishes a draft CDRH strategic plan for medical device international harmonization.[ Price : $8.95]
Three Ropes & Gray attorneys analyze three FDA draft guidances intended to modernize the 510(k) program, saying they are likely to...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based o...