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FDA warns Allergy Laboratories about CGMP violations indicating the firms quality control units are not fulfilling their responsib...[ Price : $8.95]
CDER issues a MAPP on good review practice for the clinical review of INDs.[ Price : $8.95]
FDA clears a Cochlear Limited 510(k) for the Cochlear Baha 4 Attract System, a direct bone conduction hearing device.[ Price : $8.95]
FDA updates a warning that certain Philips Medical HeartStart automated external defibrillators may be unable to deliver needed sh...[ Price : $8.95]
FDA warns Wockhardt about CGMP violations at two plants in India similar to those in an earlier Warning Letter.[ Price : $8.95]
A new CDER strategic plan outlines four major strategies the Center plans to pursue smarter regulation, scientific innovation, le...[ Price : $8.95]
FDA approves a new warning on Lundbecks anti-seizure drug Onfi (clobazam) about rare but serious skin reactions that can result in...[ Price : $8.95]
Actelion says a data monitoring committee recommended ending the DUAL-2 study of macitentan in patients with systemic sclerosis an...