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CGMP Violations Found in Allergy Laboratories Inspection

[ Price : $8.95]

FDA warns Allergy Laboratories about CGMP violations indicating the firms quality control units are not fulfilling their responsib...

IND Clinical Review MAPP

[ Price : $8.95]

CDER issues a MAPP on good review practice for the clinical review of INDs.

FDA Clears Cochlear Baha Hearing System

[ Price : $8.95]

FDA clears a Cochlear Limited 510(k) for the Cochlear Baha 4 Attract System, a direct bone conduction hearing device.

FDA Alert on Philips Defibrillators

[ Price : $8.95]

FDA updates a warning that certain Philips Medical HeartStart automated external defibrillators may be unable to deliver needed sh...

FDA Warns Wockhardt About Two India Plants

[ Price : $8.95]

FDA warns Wockhardt about CGMP violations at two plants in India similar to those in an earlier Warning Letter.

CDER Plan to Focus on Smarter Regulation, Scientific Innovation

[ Price : $8.95]

A new CDER strategic plan outlines four major strategies the Center plans to pursue smarter regulation, scientific innovation, le...

New FDA Warning on Lundbecks Onfi

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FDA approves a new warning on Lundbecks anti-seizure drug Onfi (clobazam) about rare but serious skin reactions that can result in...

Data Committee Recommends End to Macitentan Study

[ Price : $8.95]

Actelion says a data monitoring committee recommended ending the DUAL-2 study of macitentan in patients with systemic sclerosis an...

GSK Asks Changes to Generic Advair Guidance

[ Price : $8.95]

GlaxoSmithKline asks FDA to make changes in its draft guidance on standards for generic versions of the companys Advair Diskus dry...

Kidney Foundation Wants Unique Biosimilar Names

[ Price : $8.95]

The National Kidney Foundation again urges FDA to assign unique nonproprietary names to biosimilars, including those that are cons...