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Joint Panel to Review Abuse-deterrent Pain Drug

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Federal Register notice: FDA announces an 11/14 joint advisory committee meeting to discuss a SpecGx NDA for its abuse-deterrent p...

Grant Implanted Device Exception: WLF

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Washington Legal Foundation asks the Utah Supreme Court to recognize that implanted medical devices are unavoidably unsafe.

Device Coordinated Voluntary Disclosures Good: Analysis

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The Medical Device Innovation Consortium lists the many benefits arising from adoption of coordinated voluntary disclosure policie...

Comments Extended on Guide for Export Certificates

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Federal Register notice: FDA extends the comment period for a draft guidance entitled Process To Request a Review of FDAs Decision...

Comments Sought on Info Collection for INDs

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Federal Register notice: FDA seeks comments on an information collection extension entitled Investigational New Drug Application21...

CDRH Lists Guidance Docs for FY 2019

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Federal Register notice: FDA has announced the Web site location where it will post two lists of guidance documents that CDRH inte...

FDA, Canada Public Meeting on ICH Activities

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Federal Register notice: FDA announces a 10/17 regional public meeting entitled U.S. Food and Drug Administration and Health Canad...

Silver Star Brands Recalls Contaminated Products

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Silver Star Brands recalls six products for humans (including four Native Remedies and two Healthful Naturals and two PetAlive pro...

NJ Court Backs Accutane Case Dismissals

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The New Jersey Supreme Court dismisses 532 failure-to-warn cases alleging that Roche failed to provide adequate warnings about the...

Stakeholders Back Meeting Pilot Program

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Two stakeholders praise an FDA pilot meeting program for complex innovative drug trial designs.