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FDA Clears MedPro Safety Blood Collection Kit

[ Price : $8.95]

FDA clears a MedPro Safety Products 510(k) for its passive-safety winged blood collection set.

FDA Clears Medtronic Spinal System for Scoliosis

[ Price : $8.95]

FDA clears a Medtronic 510(k) for its CD Horizon Spinal System and its use in treating adolescent idiopathic scoliosis.

FDA Denies Osmotica Venlafaxine Petition

[ Price : $8.95]

FDA denies an Osmotica citizen petition asking the agency not to approve ANDAs for generic forms of its venlafaxine HCl unless the...

Abbott Asks Customers to Stop Using Some Prism Trays

[ Price : $8.95]

Abbott asks customers to stop using specified Prism HBsAg and/or Prism HIV O Plus reaction trays and obtain replacement lots.

AdvaMed Praises Shuren on 510(k) Changes

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AdvaMed CEO Stephen Ubl praises CDRH director Jeffrey Shurens support for improving the Centers effectiveness in supporting innova...

Sagent Pharmaceuticals' Generic Midazolam Approved

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FDA approves a Sagent Pharmaceuticals ANDA for four presentations of general anesthetic midazolam for injection.

IND Approved for Inhaled Nitric Oxide in Pulmonary Hypertension

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FDA approves a GeNO IND for a clinical trial with the GeNO Nitrosyl (inhaled nitric oxide) System for treating certain pulmonary h...

Advisors Back Restricted Vandetanib Use

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Members of FDAs Oncologic Drugs Advisory Committee signal support for AstraZenecas vandetanib in some thyroid cancer patients.

Comments Sought on Animal Drug User Fee Info

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Federal Register Notice; FDA seeks comments on reporting requirements for animal drug user fees.

Panel to Discuss NDA for Exocrine Pancreatic Insufficiency

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory will meet 1/12 to discuss an Alnara Pharmaceuticals NDA to treat exo...