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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 ...

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...

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 ...

FDA Proposes Drug Shortages Rule

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Federal Register Proposed rule: FDA proposes to require certain drug/biologic manufacturers to notify it electronically of a disco...

Curemark Begins Rolling NDA for Autism Therapy

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Curemark says it has begun an NDA rolling submission for CM-AT, the companys enzyme replacement therapy for autism treatment.

Invega Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Invega extended-release tablet, 12 mg was not withdrawn for reasons of safety or effe...