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Albany Molecular Research Resolves 2010 Warning Letter

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FDA issues Albany Molecular Research an inspection close-out letter lifting a 2010 Warning Letter related to its Burlington, MA as...

Hamburg Calls Compounding Bill Just a Step

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FDA commissioner Margaret Hamburg calls a drug compounding bill moving through Congress a step and not as comprehensive as the age...

How FDA Dropped Patient Warning Rule from LASIK Approvals

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FDA explains how a little-noticed change in its conditions of approval for LASIK lasers removed a patient-protection requirement t...

J&J Agrees to Pay $2.2 Billion Over Drug Marketing Violations

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Johnson & Johnson and subsidiaries Janssen Pharmaceuticals and Scios agree to pay $2.2 billion to resolve criminal and civil claim...

FDA/EMA Joint Document on Drug Design Space

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FDA and the European Medicines Agency publish a second joint question-and-answer document that provides guidance on pharmaceutical...

FDA Approves BD Rx for Morphine Sulfate Injection

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FDA approves a BD Rx NDA for morphine sulfate injection that is offered in its Simplist line of ready-to-administer prefilled inje...

Edwards Lifesciences Recalls EMBOL-X-Glide System

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Edwards Lifesciences begins a Class 1 recall of its EMBOL-X Glide Protection System due to a deformed cannula tip.

Rep. Eshoo Seeks Legislation to Free Up User Fees

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Representative Anna Eshoo (D-CA) says legislation is needed to free up all user fees that were blocked from being spent under the ...

Merck Filing BLA for HPV Vaccine by Year-end

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Merck says it will file a BLA by the end of the year for its investigational 9-valent human papillomavirus vaccine (V503) followin...

FDA Approves New Novo Nordisk Prefilled Insulin Pens

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FDA approves Novo Nordisks prefilled insulin pens NovoLog (insulin aspart [rDNA origin] injection) FlexTouch and Levemir (insulin ...