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FDA 510(k) Cleared with CLIA Waiver for Quidel Strep Test

[ Price : $8.95]

FDA issues 510(k) clearance and a Clinical Laboratory Improvement Amendments waiver for Quidel Corp.s Sofia Strep A+ Fluorescent I...

FDA Mulls Changes to Drug-induced Liver Injury Guidance

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FDA seeks input on potential revisions to a 2009 guidance on Drug-Induced Liver Injury: Premarketing Clinical Evaluation, which is...

FDA Testing Drone Technology, But Not for Inspections

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FDA says it is testing drone technology as part of its Office of Informatics and Technology Innovation emerging technologies resea...

FDA Increasing Inspection Staff in China

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FDA says it is increasing the number of drug and food inspectors posted in China.

Aptiom Print Ad Overstates Efficacy: OPDP

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CDERs Office of Prescription Drug Promotion says that a Sunovion DTC print ad for Aptiom misleadingly overstates the products effi...

Industry Using Political Clout to Block Biosimilars: Public Citizen

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Public Citizen says the biologics industry has used its political power to delay marketing of generic biologics.

FDA Sends Collection of Info on Fast-Track Drugs to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on fast track drug development programs to...

Info on Orphan Products Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a draft guidan...

Guidance on Study Data E-Submissions

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Federal Register Notice: FDA releases a guidance: Providing Regulatory Submissions in Electronic Format Standardized Study Data.

Info on Biologic Cooperative Manufacturing Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...