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USP Revises Heparin Labeling Requirements

[ Price : $8.95]

The U.S. Pharmacopeial Convention finalizes a standards revision to heparin sodium injections and heparin lock flush solutions tha...

Unusual Generic Design Defect Claim Survives Preemption

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A legal analysis by Dechert LLP attorney Michelle Hart Yeary reviews how an unusual generic design defect claim survived a preempt...

FDA Update on Pradaxa Bleeding Risks

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FDA says a recent review of data show bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding r...

FDA Approves Updates to Mercks Victrelis

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FDA approves updates to Mercks Victrelis (boceprevir) package insert and Medication Guide to include postmarketing information ab...

FDA Expanded Approval for Janssens Xarelto

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FDA expands the use of Janssen Pharmaceuticals Xarelto (rivaroxaban) to include treating deep vein thrombosis or pulmonary emboli...

FDA Option to Extend User Fee Reviews Due to Storm

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FDA says it has the option to extend user fee review action dates by two days due to the unexpected agency closure 10/29-30 becaus...

CDER Cites Burzynski Clinic Again

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CDERs Office of Prescription Drug Promotion sends the Burzynski Research Institute an untitled letter that cites Web sites, press ...

OPDP Letter Cites ONY Web Page and Promo Video

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CDER Office of Prescription Drug Promotion cites ONY Inc.s Web pages and a promotional video for Infasurf.

Petition Seeks Action Against Generic Bupropion 300mg

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Valeant Pharmaceuticals petitions FDA urging it to provide notice of the intent to withdraw remaining generic bupropion hydrochlor...

Pay-for-delay Losing Favor

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Attorney Erica Kraus says the Supreme Court may ultimately decide whether pay-for-delay agreements between innovator and generic d...