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Medical Product Firms Being Hacked Over Sensitive Info

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An Internet security firm says it is currently tracking a group that targets the email accounts of senior employees at healthcare ...

Amarin Pharma Petition on Vascepa Rejected by FDA

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FDA denies an Amarin Pharmaceuticals Ireland petition asking it to impose specific bioequivalence testing requirements on any ANDA...

Since Our Last Issue ...

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Industry news you may have missed since our last issue.

FDA Denies Most of Risperdal, Invega Petition

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FDA denies most requests in a petition seeking revocation of the pediatric indication for Risperdal, generic forms of that drug, a...

ConMed Device Correction on Defibrillator Leads

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ConMed Corp. begins an urgent device correction for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connec...

FDA Clears HeartFlows Blood Flow Analyzer Software

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FDA approves a de novo petition to allow the marketing of HeartFlows FFR-CT software, which permits health care professionals to e...

FDA Binding Recommendations Urged for Clinical Trials

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Dartmouth Institute for Health Policy and Clinical Practice researchers say one way to achieve higher quality drug approvals is to...

FDA Draft Guidance on Drug Product Tracing Information

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FDA posts a draft guidance on statute-required Standards for the Interoperable Exchange of Information for Tracing of Certain Huma...

FDA Warning for OTC Acetaminophen Products

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FDA publishes a draft guidance with a recommended label warning for OTC acetaminophen-containing products on the potential for ser...

NEWSROOM CLOSED FOR THANKSGIVING

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FDA Webview has closed its newsroom to observe the Thanksgiving holiday in the U.S. Our next overnight email bulletin will be issu...