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LASIK Dissidents Launch LasikFDA Web Site

[ Price : $8.95]

Dissident and injured LASIK patients launch a sophisticated Web site, LasikFDA.com, to counteract CDRHs LASIK Web site and present...

FDA Acts Against Papain, Balanced Salt Solutions

[ Price : $8.95]

FDA orders companies to stop making and shipping unapproved products containing papain for topical use and ophthalmic balanced sal...

Paxil Preemption Case Can Go to Trial

[ Price : $8.95]

Federal judge Ronald Buckwalter says a New Jersey failure-to-warn case against GlaxoSmithKlines Paxil is not preempted by federal ...

FDA Looking at New Bio Study for Generic Wellbutrin

[ Price : $8.95]

FDA says it has agreed to look into doing a bioequivalence study that would test generic bupropion (Glaxos Wellbutrin) in patients...

Ucyclyd Pharma Warning on Ammonul Particulate Matter

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Ucyclyd Pharma warns healthcare professionals about the possibility of particulate matter in its Ammonul Injection product.

Trial Lawyers Challenge OTC Preemption

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Trial lawyers in the Association for American Justice say FDA should not claim preemption of state product liability claims over O...

FDA Clears MBL International ELISA Kits

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FDA clears a MBL International 510(k) for the BP180 and BP230 ELISA test kits intended for use in detecting Bullous Pemphigoid.

FDA Gives AstraZeneca Additional Exclusivity on Casodex

[ Price : $8.95]

FDA grants AstraZeneca an additional six-month exclusivity period for Casodex, indicated for treating advanced prostate cancer.

Authority for CME Changes Challenged

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Attorney Arnold Friede says there are legal questions about the Accreditation Council for Continuing Medical Educations authority ...

Labopharm Submits NDA for Depression Drug

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Labopharm submits a 505(b)(2) NDA for DDS-04A (trazodone), a once-daily serotonin antagonist reuptake inhibitor indicated for trea...