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Device Discontinuance Notification Guides

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Federal Register notice: FDA makes available a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption...

Panel to Discuss 506J Device List

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Federal Register notice: FDA announces a 2/6/2024 advisory committee meeting on medical device supply chain resiliency and shortag...

Final Guide on Device Computational Modeling

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Federal Register notice: FDA makes available a final guidance entitled Assessing the Credibility of Computational Modeling and Sim...

FDA OKs AstraZeneca Breast Cancer Drug

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FDA approves an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in certain adult patients with hormone receptor...

Mercks Keytruda Gains OK in Gastric Cancer

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FDA approves a Merck NDA for Keytruda (pembrolizumab) and its use with fluoropyrimidine- and platinum-containing chemotherapy for ...

Asensus Surgical Recalls Robot Devices

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Asensus Surgical recalls its Senhance Surgical System due to malfunctions that cause unintended movement of the robotically assist...

Braun Medical Infusion Pump Recall

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Braun Medical recalls its Infusomat Space Volumetric Infusion Pump System due to faulty occlusion alarms.

FDA Approves Expanded Xtandi Use

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FDA approves Astellas Pharmas Xtandi (enzalutamide) for an expanded use treating non-metastatic castration-sensitive prostate can...

BMS Gains Approval for Lung Cancer NDA

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FDA approves a Bristol Myers Squibb NDA for Augtyro (repotrectinib) for treating adult patients with locally advanced or metastati...

Regulatory Review Determination on Rozlytrek Corrected

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Federal Register notice: FDA corrects a notice that appeared in the 7/8/2022 Federal Register that announced an agency determinati...