[ Price : $8.95]
FDA issues a guidance with its current thinking on submitting adverse event reports from drug outsourcing facilities.[ Price : $8.95]
FDAs Denver District Office warns International Medical Development Corp. that it is manufacturing adulterated and misbranded Gert...[ Price : $8.95]
FDA denies an Otsuka petition asking that approval for Alkermes Aristada be delayed or rejected.[ Price : $8.95]
FDA cites a Pharmacia & Upjohn drug manufacturing facility in Kalamazoo, MI for GMP issues following a July inspection.[ Price : $8.95]
Attorney Jennifer Thomas says companies should ensure that promotional activities are given a thorough medical, legal, and regulat...[ Price : $8.95]
Attorney James Beck refuses cases that have held that making changes to a branded drugs formula is preempted under the Supreme Cou...[ Price : $8.95]
FDA posts a new electronic common technical document guide entitled eCTD Technical Conformance Guide, Version 1.0.[ Price : $8.95]
FDA says it will not revise and restrict a 2014 safety warning issued about the risk of rare but serious neurologic problems assoc...