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FDA issues a complete response letter to an ARS Pharmaceuticals NDA for neffy, calling for a repeat-dose study.[ 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Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based o...[ Price : $8.95]
FDA says it is converting its medical device Accreditation Scheme for Conformity Assessment from a pilot to a permanent program.[ Price : $8.95]
A federal judge sentences Byron A. Marshall of Houston, TX to 300 months in federal prison for his role in leading a counterfeit d...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based o...