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Iowa Supreme Court Hits Innovator Liability

[ Price : $8.95]

Victor Schwartz and Phil Goldberg say the Iowa Supreme Court got it right in rejecting the theory of innovator liability that woul...

Report on Evaluating REMS

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Federal Register Notice: FDA releases a draft report: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS...

Public Meeting on Opioid Medications

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Federal Register Notice: FDA plans a public meeting 10/30-31 to discuss the development, assessment, and regulation of abuse-deter...

Workshop on Device and Healthcare Cybersecurity

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Federal Register Notice: FDA plans a public workshop 10/21-22: Collaborative Approaches for Medical Device and Healthcare Cybersec...

FDA Character Space Limitations Guidance Draws Fire

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Trade organizations say that an FDA draft guidance on manufacturer communication on Internet/social media platforms with character...

Industry Seeks Context in HHS Reports on MD Payments

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Three industry trade groups ask CMS to make sure there is background contextual information when the agency begins reporting physi...

FDA Urged to Reconsider Misinformation Draft Guidance

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Trade organizations ask FDA to scale back a draft guidance on responsibility for correcting product misinformation posted by third...

Be Sure FDA Promotes Biologic Drug Access: Dellums

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Former Rep. Ron Dellums says the decision FDA makes on how to name biosimilars can affect how successful the Affordable Care Act i...

Drop Exclusion Threat When Firms Negotiate Settlements: WLF

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The Washington Legal Foundation urges HHS to change its policy on using the threat of exclusion from participation in federal heal...

IDE Violations Found in Brava Study

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FDA warns Brava about IDE violations in its role as sponsor of a clinical study on breast reconstruction and augmentation using th...