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Error Corrected in Biologics Regs

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Federal Register Final rule: FDA amends the biologics regulations to correct an error.

More Deaths With Investigational Antibiotic Than a Comparator: FDA

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FDA advisory committee briefing documents say Arpidas investigational antibiotic iclaprim was possibly associated with more deaths...

FDA Pushes Back Diabetes Drug Panel Meeting

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FDA tells Novo Nordisk that a planned advisory committee meeting for liraglutide on 3/2/09 has been rescheduled for 4/2 or 4/3.

E14 Guidance Clarified

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FDA issues a questions-and-answers clarification to the harmonized E14 guidance on QT/QTc Interval Prolongation and Proarrhythmic ...

FDA Needs Right Kind of Reform: Miller

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Former FDAer Henry Miller warns that those leading the HHS/FDA transition may look for a commissioner who will make FDAs problems ...

DTC Spend Continues to Slide

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TNS Media Intelligence says drug company spending on DTC ads continued to decline in the first eight months of this year.

CDRH Complaints are Latest Showing of Topside Impotence

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Editor Jim Dickinson reviews the discouraging history of FDA leadership impotence in handling the kind of allegations just made to...

Panelists Suggest Revised Filler Labeling

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FDA advisors recommend revised dermal filler labeling to provide better risk information.

Lumpkin Given FDLI Distinguished Service Award

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FDLI awards FDA deputy commissioner for international and special programs Murray Lumpkin its 2009 Distinguished Service and Leade...

CGMP, Other Problems at Deltex Pharmaceuticals

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FDAs Dallas District Office warns Deltex Pharmaceuticals about cGMP problems at its drug manufacturing facility, along with market...