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FDA issues 510(k) clearance and a Clinical Laboratory Improvement Amendments waiver for Quidel Corp.s Sofia Strep A+ Fluorescent I...[ Price : $8.95]
FDA seeks input on potential revisions to a 2009 guidance on Drug-Induced Liver Injury: Premarketing Clinical Evaluation, which is...[ Price : $8.95]
FDA says it is testing drone technology as part of its Office of Informatics and Technology Innovation emerging technologies resea...[ Price : $8.95]
FDA says it is increasing the number of drug and food inspectors posted in China.[ Price : $8.95]
CDERs Office of Prescription Drug Promotion says that a Sunovion DTC print ad for Aptiom misleadingly overstates the products effi...[ Price : $8.95]
Public Citizen says the biologics industry has used its political power to delay marketing of generic biologics.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on a guidance on fast track drug development programs to...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a draft guidan...