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FDA Denies Petition on Oxycodone API Impurity Limit

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FDA rejects a Rhodes Technologies citizen petition seeking an agency commitment to maintain a certain impurity limit for oxycodone...

Safety Alert on Compounded Drugs After Firm Refuses to Recall

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FDA reminds health care providers about safety concerns with all sterile compounded drug products made and distributed by NuVision...

Seattle Genetics Begins Phase 2 Adcetris Trial in Lymphoma Patients

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Seattle Genetics begins a Phase 2 clinical trial evaluating Adcetris (brentuximab vedotin) in combination with the current standar...

FDA Orphan Status for Leukemia Drug

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FDA grants an orphan drug designation to Epizyme for its EPZ-5676, a small molecule inhibitor of the DOT1L histone methyltransfera...

FDA Sends Info on Product Jurisdiction to OMB

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Federal Register Notice: FDA submits to the Office of Management and Budget a proposed collection of information on product jurisd...

Glaxo Gains Approval for Flulaval Vaccine

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FDA approves GlaxoSmithKlines Flulaval Quadrivalent (influenza virus vaccine) for the active immunization of those three years of ...

Foreign FDA Inspections on the Rise

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FDA officials say foreign inspections are on the rise, with inspections in India jumping 21% in 2012 compared to the year before.

Create Trusted Importer Program: PhRMA

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Stakeholders urge FDA to differentiate risks posed by various drug importers and introduce a trusted importer program.

FDA Approves Boxed Warnings for Depakote, Nizoral

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FDA approves labeling changes for 34 drug products, including Boxed Warnings for Depakote and Nizoral.

FDA Clears Immunetics BacTx Test

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FDA clears an Immunetics 510(k) for its BacTx rapid test for bacteria in apheresis platelets.