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Industry Concerns with Predicate Device Guide

[ Price : $8.95]

Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an ...

Belmont Eyecare Selling Unapproved Eye Drops: FDA

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FDA warns Chicago, IL-based Belmont Eyecare it is illegally marketing six types of eye drops that are unapproved new drugs.

MONARCH 3 Results Show Verzenio Success: Lilly

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Lilly says that MONARCH 3 trial results indicate its Verzenio plus an aromatase inhibitor had a better survival rate than the cont...

How FDA One-stop PJOs Help Combo Industry

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A recent conference panel describes how FDA Product Jurisdiction Officers provide one-stop communication and coordination services...

No Safety Issues in Biosimilar Switches: CDER Research

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CDER researchers say their statistical analysis demonstrates that switching between biosimilars and their reference products is no...

ImmunoGen sBLA for Elahere Seeks Full Approval

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FDA accepts for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravta...

Pentagon Hits FDA on Generic Testing

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A lengthy Bloomberg News article outlines concerns the Defense Department, health systems, and Congress have about FDAs ability to...

Roche Positive Results with Breast Cancer Drug

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Roche says it will discuss with FDA and other health authorities positive results from the Phase 3 INAVO120 study of inavolisib in...

Device Tracking Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Device Tracking 21 CFR Pa...

FDA Releases Novartis Untitled Letter on GMPs

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An FDA untitled letter cautions Novartis that its manufacturing facility in Morris Plains, NJ, is deviating from current good manu...