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Bunnell Recalls Ventilator Patient Circuits

[ Price : $8.95]

Bunnell Inc. recalls its Life Pulse High-Frequency Ventilator Patient Circuits.

FDA Submits Info on Postmarket Reporting to OMB

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

FDA Sends Info on Graphic Cigarette Labels

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Federal Register Notice; FDA submits a reinstatement collection on graphic cigarette labels to the Office of Management and Budget...

Meeting on Renewing Animal Drug User Fee Act

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Federal Register Notice: FDA plans a meeting 12/18 on the reauthorization of the Animal Drug User Fee Act.

Guidance on Limiting Phthalates as Excipients

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A CDER guidance recommends against using DBP and DEHP as excipients in drug and biologic products.

CDER Denies Generic Copaxone Restriction Request

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FDA denies a Teva petition seeking limitations on approving generic forms of Copaxone without comment on specific requirements it ...

Reviewers Question Zohydro ER Abuse Potential

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CDER medical reviewers say they believe that Zogenix Zohydro ER may be more subject to abuse than combination hydrocodone products...

Chelsea Therapeutics: Positive Results in Parkinsons Trial

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Chelsea Therapeutics International reports positive preliminary results for Study 306B, a Phase 3 trial evaluating Northera for tr...

CDRH Lists 6 Strategic Priorities

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CDRH releases its six strategic priorities for 2013.

FDA, AstraZeneca Agree on Faslodex Label Update

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FDA and AstraZeneca reach agreement on label changes for Faslodex injection that updates results from the companys CONFIRM trial i...