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FDA Posts Transcript of Device User Fee Program Meeting

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FDA posts a transcript of its 11/2 public meeting on Medical Device User Fee Amendments that discussed proposed recommendations fo...

Guidance on Clin Pharm Labeling for Drugs

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Federal Register Notice: FDA makes available a guidance entitled Clinical Pharmacology Section of Labeling for Human Prescription ...

Comments on Device GMPs and Quality System Regulations

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Federal Register Notice: FDA seeks comments on an information collection extension request related to Medical Device: Current Good...

Comments Sought on Symbols on IVD Labels

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Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection related to a recommended glos...

Regulatory Review Period for BMSs Opdivo

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Federal Register Notice: FDA determines the regulatory review period for Bristol Myers Squibbs lung cancer therapy Opdivo (nivolum...

Regulatory Review Period for Novo Nordisks Tresiba

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Federal Register Notice: FDA determines the regulatory review period for Novo Nordisks diabetes therapy Tresiba (insulin degludec ...

CVM Revises Extralabel Use Guide for Medicated Feed

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FDAs Center for Veterinary Medicine (CVM) issues a revised compliance policy guide, effective immediately, on the extralabel use o...

Jury Awards $1 Billion on Hip Implant Case

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A federal jury in Dallas returns a combined verdict of more than $1 billion on behalf of six people who suffered serious medical c...

FDA Approves Lillys Jardiance to Reduce CV Death

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FDA approves a new indication for Eli Lillys Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patient...

FDA Steps to Improve Combination Product Review

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FDA steps up its focus on combination products and plans to finalize its guidance on human factors and GMPs this coming year.