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Court Dismisses Takeda Whistleblower Fraud-on-FDA Case

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A Massachusetts federal court dismisses a Takeda whistleblower case alleging the company failed to report adverse events involving...

Merck Files NDA for New Insomnia Drug

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Merck submits a standard review NDA for suvorexant, a controlled substance drug indicated for treating insomnia.

Curosurf Pitch Letter False and Misleading: OPDP

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CDERs Office of Prescription Drug Promotion says a Curosurf pitch letter and news release omit important risk information and incl...

FDA Appeals Foreign Thiopental Ban

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FDA appeals a federal judges ruling that would ban use of foreign-made sodium pentothal in state corrections system execution leth...

Panel to Discuss Zogenix Zohydro ER for Chronic Pain

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FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet 12/7 to discuss Zogenix Inc.s NDA for Zohydro ER for mana...

FDA OKs Kips Bay IDE for eSVS Mesh

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FDA grants approval with conditions to Kips Bay Medical for an Investigational Device Exemption to include four U.S. study sites o...

Incomplete Process Validation Most Common Biologics Problem

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CBERs Nicole Trudel tells the RAPS annual meeting that process validation issues are the most common she finds in biologics pre-li...

FDA Approves Excor Pediatric Heart Failure System

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FDA approves a Berlin Heart humanitarian device exemption for the Excor Pediatric System, a device intended to support the weakene...

Product Approval Summaries

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FDA Review posts product approval summaries for the week ending 12/16.

Industry Supports FDA Proposals on Biosimilars User Fees

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Presenters at an FDA-sponsored public meeting to consider a proposed user fee program for biosimilars offer uniform support for th...