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BD Announces FDA 510(K) Submission of Rapid Molecular Test
BD Diagnostics, a segment of BD (Becton, Dickinson and Company) , announced that it has made a 510(k) submission to the U.S. Food and Drug Administrat...

MedImmune Resolves FDA Observations Regarding Manufacturing Process for FluMist
MedImmune announced that it has resolved the observations made by the U.S. Food and Drug Administration (FDA) during an annual inspection of the compa...

Singular Security Delivers First Comprehensive Security Compliance and Policy Configuration Services for Enterprise Users
Singular Security, provider of comprehensive security configuration management services, today announced the availability of Policy Compliance ActionP...

FDA Approves Investigational New Drug Application for 'Fat Melting' Injections
he Aesthetic Surgery Education and Research Foundation (ASERF) announced that it has received approval from the U.S. Food and Drug Administration to i...

Watson Receives First FDA Approval for Manufacturing Product in India
Watson Pharmaceuticals, a specialty pharmaceutical company, announced that it has received its first U.S. Food and Drug Administration (FDA) product a...

Somatuline Depot Receives FDA Marketing Approval for the Treatment of Acromegaly
Tercica announced that its partner Ipsen (Euronext:IPN) has received notice of approval from the U.S. Food and Drug Administration (FDA) for marketing...

FDA and Conformia Deliver Joint Presentation to Annual Regulatory and Compliance Symposium at Harvard
Conformia, one of the FDA's Cooperative Research and Development Agreement (CRADA) Partners, joined forces with the Food and Drug Administration (FDA)...

Conformia, one of the FDA's Cooperative Research and Development Agreement (CRADA) Partners, joined forces with the Food and Drug Administration (FDA) on August 23, 2007, in a presentation focusing on the FDA's Quality by Design (QbD) initiative at the Th
Abiomed, announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin its pivotal clinical trial in the Un...

New Roche West Nile Virus Blood Screening Test Gets FDA Approval
Roche Diagnostics announced that the US Food & Drug Administration (FDA) today approved its biologics license application for the company's test for d...

SYSPRO Enhances SYSPRO CRM Software to Facilitate FDA Compliance
SYSPRO, provider of enterprise software, has announced significant enhancements to the SYSPRO CRM (Customer Relationship Management) solution. These m...

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