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Q Therapeutics ALS Cell Product Gains Orphan Status

[ Price : $8.95]

FDA grants Q Therapeutics an Orphan Drug Designation for its Q-Cells product (for treating amyotrophic lateral sclerosis.

CDRH Reorganizes Compliance Office

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CDRH finalizes a planned Office of Compliance reorganization that places more emphasis on compliance with advertising/promotion re...

$2 Million in Hi-Tech Supplements Seized After it Sues FDA

[ Price : $8.95]

FDA orders Hi-Tech dietary supplements seized as part of its efforts to remove products containing DMAA from the marketplace.

FDA Calls Medtronic Field Action a Class 1 Recall

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FDA says that a recent Medtronic field action involving certain guidewires is a Class 1 recall.

Group Seeks More Clarification in FDA-483 Citations

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The American Herbal Products Association asks FDA to amend its inspection policy to require its investigators to cite applicable r...

Natures Pharmacy Recalls Compounded Drugs

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Natures Pharmacy and Compounding Center (Asheville, NC) recalls all unexpired lots of sterile products due to FDA inspection conce...

Info on Dietary Ingredient Premarket Notification Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on premarket notification for a new dietary ingredient t...

Sanofi Scraps Cancer Therapy Due to Safety Concerns

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Sanofi decides to cancel the development of its investigational JAK2 inhibitor SAR302503 (fedratinib) due to safety concerns.

FDA Updates Form 356h and Form 2253

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FDA releases updated FDA Form-356h and FDA Form-2253, as well as accompanying instructions.

Luitpold Petitions FDA for Requirements on Iron Products

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A just-posted citizen petition from Luitpold Pharmaceuticals requests that FDA require that any NDA for injectable iron for treati...