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FDA Clears Accuray CyberKnife

[ Price : $8.95]

FDA clears an Accuray 510(k) for the CyberKnife M6 Series, intended for use in stereotactic radiosurgery and stereotactic body rad...

Clarification Sought in Device Presubmission Guidance

[ Price : $8.95]

Stakeholders ask FDA to clarify and change its draft guidance on pre-submission medical device program and meetings with agency st...

Abiomed Faces Probe on Impella Marketing

[ Price : $8.95]

Abiomed says the United States Attorney's Office for the District of Columbia is conducting an investigation focused on its market...

Pew Wants Stronger Animal Antibiotic Regs, Reporting

[ Price : $8.95]

The Pew Charitable Trusts says that FDA should strengthen its requirements for animal antibiotic regulation and reporting.

Aerie Reports Positive Results for Glaucoma Drug Combo

[ Price : $8.95]

Aerie Pharmaceuticals reports positive Phase 2a clinical trial results from a combination of its Rho kinase inhibitor AR-12286 wit...

Markey Releases Draft of Compounding Act

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Rep. Edward J. Markey (D-MA) releases draft legislation he intends to introduce 11/2 to give FDA more authority to regulate compou...

Additional Recalled NECC Drugs Show Contamination

[ Price : $8.95]

FDA and CDC say bacterial contamination was found in two additional recalled NECC products.

FDA Complete Response on Cornerstone Therapeutics NDA

[ Price : $8.95]

FDA issues Cornerstone Therapeutics a complete response letter on its NDA for lixivaptan, indicated for treating symptomatic hyper...

New Approach Suggested for Generic Drug Adverse Event Liability

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Researchers say a new approach is needed to ensure updated safety information on generic drug labels and compensate patients who s...

FDA Sets 6/15/2013 User Fee Date for Delcath Systems NDA

[ Price : $8.95]

FDA sets a 6/15/2013 user fee review action target date for a Delcath Systems NDA for its proprietary chemosaturation system with ...