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FDA issues Dr. Reddys a three-observation Form FDA-483 following a pre-approval inspection and Good Manufacturing Practices inspec...[ Price : $8.95]
FDA grants de novo authorization for Caristo Diagnostics CaRi-Heart coronary inflammation technology.[ Price : $8.95]
An FDA advisory committee votes against recommending approval for Capricor Therapeutics' investigational cell therapy deramiocel, ...[ Price : $8.95]
Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug a...[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at the Hayward, CA-based Allure Labs drug manufacturing f...[ Price : $8.95]
FDA reviewers raise concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of...[ Price : $8.95]
FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot ped...[ Price : $8.95]
FDA warns Hiram, GA-based VasoCorp Inc. that it is illegally marketing misbranded unapproved new drugs.