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FDA Complete Response Letter on Moxduo NDA

[ Price : $8.95]

FDA issues QRxPharma a complete response letter on its Moxduo NDA, indicated for treating moderate to severe acute pain.

FDA Warns on PML Adverse Event with Gilenya

[ Price : $8.95]

FDA warns that a multiple sclerosis patient taking Novartis Gilenya (fingolimod) developed a rare and serious brain infection.

Courts Questioning False Claims Act Implied Certification

[ Price : $8.95]

Attorneys Brian Dunphy and Ellyn Sternfield say federal judges are beginning to question whether to permit False Claims Act suits ...

Cubist Recalls 4 Cubicin Lots

[ Price : $8.95]

Cubist Pharmaceuticals recalls four lots of Cubicin (daptomycin for injection) due to the presence of particulate matter in some v...

FDA Accepts Pharmacyclics NDA for B-cell Malignancy Drug

[ Price : $8.95]

FDA accepts for review a Pharmacyclics NDA for ibrutinib for treating two B-cell malignancy indications.

BD Rx Gains Approval for Generic Zofran

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FDA approves a BD Rx ANDA for ready-to-administer prefilled ondansetron, USP 4mg/2mL (2mg/mL), a generic copy of GlaxoSmithKlines ...

FDA Updates Non-clinical Engineering Stent Guidance

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FDA publishes a short update with revised recommendations for four specific sections of its guidance on non-clinical engineering t...

Stryker Class 1 Recall of Cervical Spine Plate

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Stryker Spine recalls its Oasys Midline Occiput Plate after receiving reports about post-operative fracture of the pin that connec...

Another Drug Recall Traced to Contract Testing Lab

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FDA says another drug compounding pharmacy has recalled products due to concerns about the adequacy of testing performed by contra...

FDA Corrects Errors in PDUFA Rates Notice

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Federal Register Notice: FDA corrects four errors in an 8/2 Federal Register notice on prescription drug user fee rates for FY 201...