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Purdue Wants Restrictions on Butrans Follow-ons

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Purdue Pharma asks FDA not to approve any ANDAs or new drug applications referencing its Butrans transdermal system unless the fol...

Gilead Seeks NCE Exclusivity for Stribild

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Gilead asks FDA to reconsider its decision not to grant NCE exclusivity to its Stribild in light of a recent DC federal court deci...

FDA Working with EMA in 2 New Clusters

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FDAers Jonathan Goldsmith and Sandra Kweder describe the work of two new partnership clusters with EMA staff.

Multiple Animal Drug Violations Found at Vetix

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FDAs Cincinnati District Office warns Vetix about multiple violations in its manufacture and distribution of animal drug products....

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Eagle Pharmacy, SaveWay Compounding Pharmacy, U.S. Specialty Formulations, Unive...

Medtronic Recalls Neurovascular Products Due to Coating Issue

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Medtronic Neurovascular Products recalls certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celera...

Multiple Violations at U.S. Specialty Formulations

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FDAs Philadelphia District Office warns U.S. Specialty Formulations about violations in its work as a compounded drug outsourcing ...

6 Goals in CBER Strategic Plan

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CBER extends its strategic plan for two years with six goals and associated objectives and strategies.

Teva to Respond to Godollo WL Next Month

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Teva says it will respond 11/4 to an FDA Warning Letter on its Godollo, Hungary, facility that manufactures sterile injectable med...

Clarifications Sought in Diagnostic Device Guidance

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Three trade associations ask FDA to clarify issues in a draft guidance on co-development of companion diagnostics with therapeutic...