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Patent Suit Filed on Opana ANDA

[ Price : $8.95]

Endo and Pennwest file suit against Impax protesting its ANDA for oxymorphone HCl extended release tablets.

Info on Glossary for IVD Labels Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a recommended glossary and education outreach to suppor...

Info on Device Third-Party Review Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on device third-party review to the Office of Management a...

Info on CGMP for Medicated Feeds Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on CGMP regulations for medicated feeds to the Office of...

MOU with Feed Control Officials

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Federal Register Notice: FDA provides a memorandum of understanding between FDA and the Association of American Feed Control Offic...

FDA Clears Alphatecs Pedicle Screw

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FDA clears an Alphatec Holdings 510(k) for the Zodiac Luxe 4mm diameter pedicle screw for use with all Zodiac spinal disorder solu...

FDA Accepts Ranexa sNDA and NDA

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FDA accepts for filing a CV Therapeutics sNDA and NDA for expanded indications for Ranexa.

Info on Animal Drug User Fees Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on animal drug user fees and fee waivers and reductions to...

Move to DTC Infomercials: Zifkin

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Zephyr Media Group president Dan Zifkin says drug companies should consider abandoning one-minute TV spots for 30-minute infomerci...

Update on Antibiotics in Aquarium Fish

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Consulting editor John Scharmann updates information on the status of human-use antibiotics in home aquariums.