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J&J Bladder Cancer Drug Under Review

[ Price : $8.95]

FDA accepts for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug releasing system for treating certa...

Getinge/Maquet Recalls VasoView HemoPro 2 Devices

[ Price : $8.95]

Getinge and its subsidiary Maquet Cardiovascular recall the VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting ...

23 No-Longer-Marketed Generics Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they told the agency that the drug prod...

Vanda Can Seek Tradipitant Hearing: FDA Notice

[ Price : $8.95]

FDA proposes to deny a Vanda NDA for tradipitant and offers the company an opportunity to seek a commissioners hearing on the deni...

7 QS Issues at 3 Integra Facilities

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FDA warns Integra Lifesciences about Quality System Regulation violations in the manufacturing of neurological and neurosurgical m...

Hologic QS and MDR Violations

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FDA warns Marlborough, MA-based Hologic about Quality System and Medical Device Reporting violations in its production of implanta...

Novo Nordisk Wins Priority Review Voucher

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Federal Register notice: FDA issues Novo Nordisk a priority review voucher for gaining approval for its hemophilia drug Alhemo (co...

12 No-Longer-Marketed NDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws the approval of 12 NDAs from multiple applicants because they are no longer marketed.

OIG Faults 3 of 24 FDA Accelerated Approvals

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The HHS Inspector General raises concerns about three of 24 drugs approved through the FDA accelerated approval pathway.

Nitrosamine CPCA Expedites Drug Approvals: FDA

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FDA says a new method of determining an acceptable intake limit for nitrosamine impurities in drugs that it helped to develop has ...