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FDA Update on Pradaxa Bleeding Risks

[ Price : $8.95]

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

[ Price : $8.95]

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...

FDA Clears Accuray CyberKnife

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FDA clears an Accuray 510(k) for the CyberKnife M6 Series, intended for use in stereotactic radiosurgery and stereotactic body rad...

Clarification Sought in Device Presubmission Guidance

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Stakeholders ask FDA to clarify and change its draft guidance on pre-submission medical device program and meetings with agency st...