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Latest FDA Warning Letters

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

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...

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...

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...

FDA Approves, Denies Parts of Generic Estrace Petition

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FDA says it will require a clinical endpoint study including an analysis of adverse events for ANDAs citing Warner Chilcotts Estra...

Custom Device Exemption Guidance Out

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FDA issues a guidance on its implementation of the revised custom device exemption from the FDA Safety and Innovation Act.

Amgen Files BLA for Blinatumomab in Leukemia

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Amgen files a BLA for blinatumomab, seeking approval for the investigational bispecific T cell engager (BiTE) antibody construct f...