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FDA Wants More Informed Consent Flexibility

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FDA says it wants to give institutional review boards some greater flexibility to waive or alter informed consent requirements und...

Steps Needed to Speed Biosimilar Market Entry: Study

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Harvard Medical School researchers outline several steps that FDA and Congress could take to increase the number of biosimilars av...

Lumendi 510(k) for Endoscopic Polyp Surgery

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FDA clears a Lumendi 510(k) for its DiLumen EIP technology with suture loops placed in the skirt along the trailing edge of the fo...

Ardelyx NDA Accepted for Irritable Bowel Drug

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FDA accepts for review an Ardelyx NDA for tenapanor for treating patients with irritable bowel syndrome with constipation.

Repeat QS Violations in US Vascular Inspection

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FDA warns US Vascular about Quality System and Medical Device Reporting violations in its production of VascuLab devices used in v...

StemGenex Product Does Not Meet Legal Requirements: FDA

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FDA warns StemGenex about multiple violations in its production of a stromal vascular fraction product.

FDA to Study Oncology Drug Professional Promotion Disclosures

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FDA describes professional promotion research it wants to conduct about oncology drug disclosures.

Drug Recalls Up 19% in 2018 Q3: Stericycle

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The Stericycle Recall Index for the third quarter of 2018 shows an increase in drug recalls and a decrease in medical device recal...

Priority Review for Lynparza sNDA in Ovarian Cancer

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FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) as a maintenance treatment in ce...

Sen. Grassley Seeks FDA Response on Cybersecurity Report

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Sen. Judiciary Committee chairman Chuck Grassley (R-IA) steps up pressure on FDA after a recent HHS Inspector General (OIG) report...