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Comments Sought on Indexing Unapproved Animal Drugs

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Federal Register Notice; FDA seeks comments on indexing legally marketed unapproved new animal drugs for minor species.

Comments Sought on Indexing Approved Animal Drugs

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on indexing legally marketed new animal drugs for minor species.

Info on Clinical Efficacy in Labeling Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a study of clinical efficacy information in professiona...

Q&A Guidance on Residual Solvents in Animal Drugs

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Federal Register Notice: FDA releases a draft guidance answering questions on CVMs implementation of USP residual solvents in anim...

FDA Clears MedPro Safety Blood Collection Kit

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

FDA Clears Medtronic Spinal System for Scoliosis

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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

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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

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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.