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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...

FDA Clears Life Spine Long Bow Interbody System

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FDA clears a Life Spine 510(k) for the Long Bow Expandable Lateral Interbody System.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Brava and West Coast Laboratories.

FDA Aims to Curb Drug Buying from Rogue Wholesalers

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FDA launches a new educational program to protect healthcare professionals from purchasing potentially unsafe drug products from a...

Iowa Supreme Court Hits Innovator Liability

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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...

Fast Track for MedImmune Anti-pneumonia Biologic

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FDA grants MedImmune a fast track designation for its investigational monoclonal antibody MEDI3902 for preventing nosocomial pneum...