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New Boxed Warning for Immune Globulin Products

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FDA announces addition of a Boxed Warning and other labeling changes for human immune globulin products.

FDA Approves Pfizer sNDA for Arthritis Drug

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FDA approves a Pfizer supplemental NDA for its arthritis drug Xeljanz (tofacitinib citrate) to include additional patient-reported...

FDA Accepts AstraZeneca NDA for Naloxegol

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FDA accepts an AstraZeneca NDA for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist, indicated for ...

Q Therapeutics ALS Cell Product Gains Orphan Status

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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

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

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...

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.