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FDA Posts Therapeutic Data Standards

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Federal Register Notice: FDA posts on its Web site a roadmap of its current thinking on therapeutic priority area data standards f...

FDA Clears TomTec Imaging Software

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FDA clears a TomTec Imaging Systems 510(k) for its new Image-Com 5 software solution.

ICH Guidance on Q11 Drug Substance Development

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A final ICH guidance on Q11 Development and Manufacture of Drug Substances describes approaches to developing and understanding th...

Public Citizen Calls for Probe on CMS Role in Compounding

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Public Citizens Health Research Group has called for an HHS Inspector General investigation into whether financial incentives crea...

HeartSine Class 1 Recall on Samaritan Defibrillators

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HeartSine begins a Class 1 recall involving certain Samaritan 300/300P Public Access Defibrillators after determining they may i...

FDA Approves Expanded Use for Glaxos Promacta

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FDA approves GlaxoSmithKlines Promacta for treating thrombocytopenia in patients with chronic hepatitis C.

FDA Amends Dates on Device ID System Rule

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Federal Register Notice: FDA amends its 7/10 proposed rule on a unique device identification system to change the proposed effecti...

Comments Sought on Custom Device Exemption

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Federal Register Notice: FDA seeks information on appropriate uses of the custom device exemption under the Food and Drug Administ...

House Committee Seeks FDA Timelines on NECC Actions

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House Energy and Commerce Republican leaders ask FDA commissioner Margaret Hamburg for timelines and internal communications relat...

Judge Tosses Ex-Pfizer Employees Whistleblower Suit

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A federal judge dismisses a former Pfizer employee's whistleblower suit alleging that the company illegally promoted its cholester...