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Alcon Should Stop Superiority Claims About Contact Lens: BBB

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The Better Business Bureaus National Advertising Division recommends that Alcon Laboratories stop making certain comparative super...

AcelRx Planning NDA Resubmission for Zalviso

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AcelRx Pharmaceuticals says it will resubmit early next year its NDA for pain drug Zalviso (sufentanil sublingual tablet system), ...

IoM Workshop Summary on Benefit/Risk Uncertainty

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The Institute of Medicine posts a summary report of its public workshops held earlier this year on advancing the development of mo...

FDA Reopens Comment Period on Social Media Guidances

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FDAs Office of Prescription Drug Promotion reopens for 30 days the comment period for two recent draft social media guidances.

FDA Safety Alert on Asthma Drug Xolair

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FDA issues a drug safety alert on Genentechs Xolair (omalizumab) due to a slightly elevated risk of cardiovascular and cerebrovasc...

FDA Tags Novartis Zortress with Potential Safety Signal

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FDA says it has identified a potential safety signal with Novartis Zortress (everolimus) oral tablets, indicated for preventing ki...

Comments Sought on Informed Consent Guidance

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Federal Register Notice: FDA reopens the comment period for a draft guidance on Informed Consent Information Sheet.

List of Approved PMAs Published

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Federal Register Notice: FDA publishes list of approved PMAs and their safety and effectiveness summaries.

OMB OKs Info Collection on Animal Drug User Fees

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on animal drug use...

FDA Sends Info Collection on GLP Regs to OMB

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