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CDER Supports C-Path Pancreatic Markers

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The CDER Biomarker Qualification Program says it supports four pancreatic injury microRNA biomarkers identified and evaluated by t...

FDA Patient Medication Information Highlighted

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Two Sheppard Mullin attorneys describe FDAs latest effort to improve written patient-facing drug safety and efficacy information.

2seventy bio Leukemia Trial Paused

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2seventy bio says its Seattle Childrens partner has paused a Phase 1 pediatric acute myeloid leukemia trial following a patient fa...

FDA OKs Amneals Pemrydi

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FDA approves an Amneal Pharmaceuticals 505(b)(2) for Pemrydi RTU, a ready-to-use version of pemetrexed for injection.

Starton OKd for Multiple Myeloma Trial

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FDA gives Starton Therapeutics the green light to proceed with a Phase 1b clinical trial of its Star-LLD investigational continuou...

NeuroOne Medical 510(k) for Ablation System

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NeuroOne Medical Technologies files a 510(k) for its OneRF Ablation System.

Device Software Submission Guidance

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FDA publishes a guidance on recommended content of premarket submissions for software contained in medical devices.

A&Z Selling Illegal New Kids Drug

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FDA warns Hauppauge, NY-based A&Z Pharmaceutical about illegally marketing an unapproved childrens calcium drug.

Recorlev Web Pages False or Misleading: FDA

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The CDER Office of Prescription Drug Promotion says Xeris Web pages for Recorlev create a misleading impression about the drugs ef...

FDA Rare Disease ARC Program Update

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CDER associate director for rare diseases Kerry Jo Lee highlights the one-year successes of the Accelerating Rare disease Cure pro...