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Academics Urge FDA to Simplify Breast Density Notifications

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A JAMA viewpoint article urges FDA to appropriately test for readability and general literacy its breast density notification lang...

DoJ Indictment on Unapproved Drugs

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The Department of Justice announces an indictment charging Marina Sievert (Dunedin, FL) with introducing into interstate commerce ...

Some Medical Gloves Removed From Shortage List

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FDA updates its device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC) that were in short supply due...

Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program

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FDA announces a 3/28-29/2023 advisory committee meeting to discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation ...

FDA Hits 2 QuVA Pharma Facilities with 483s

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FDA releases two Form FDA-483s after inspecting QuVa Pharma outsourcing facilities in New Jersey and Texas.

Dear Doctor Letters Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Improving Communication of Important Safety...

Mirati Gets Accelerated OK for Lung Cancer Drug

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FDA grants accelerated approval to Mirati Therapeutics for its Krazati (adagrasib) NDA, indicated for treating adult patients with...

Academics Urge Tougher FDA Stance on Accelerated NDAs

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Two JAMA articles say FDA should seek to tweak its accelerated approval program to make it easier for it to pull an approval if a ...

Device Voluntary Malfunction Summary Reporting Guide

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Federal Register notice: FDA is releases a draft guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manu...

Guide on Device Human Factors Submission Info

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Federal Register notice: FDA posts a draft guidance entitled Content of Human Factors Information in Medical Device Marketing Subm...