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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...

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...

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...

Dexcom Glucose Monitor Approved by FDA

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FDA approves Dexcoms continuous glucose monitoring system, the Dexcom G4 PLATINUM.

PolyMedix Receives FDA Guidance on Brilacidin

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PolyMedix receives guidance in a meeting with FDA on a Phase 2B protocol for its brilacidin in treating acute bacterial skin and s...

Info on Safety Labeling Changes Guidance Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a draft guidance on safety labeling changes to the Of...

Public Hearing on Potentially Threatening Pathogens

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Federal Register Notice; FDA plans a public hearing 12/18 to gain input on establishing a list of qualifying pathogens that have t...

FDA Inspection of Janssen Biotech Cites Remicade Manufacturing

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FDA cites Janssen Biotechs Malvern, PA facility for failing to adequately investigate unexplained discrepancies related to Remicad...