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Allergan sBLA for Botox Accepted for Review

[ Price : $8.95]

FDA accepts for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improveme...

FDA Warns of High-Risk Issue With BD Intraosseous Needle Sets

[ Price : $8.95]

FDA issues an early alert warning healthcare providers not to use certain Becton Dickinson intraosseous vascular access needle set...

Liebel-Flarsheim Recalls Optiray Imaging Contrast Agent

[ Price : $8.95]

Liebel-Flarsheim recalls one lot of its Optiray Imaging Bulk Package 350 radiographic contrast agent after identifying particulate...

Electronic Common Document Updated Support Package Out

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The International Council for Harmonization says its electronic common technical document working group has issued updated support...

Arrowhead Acquires Priority Voucher to Speed Plozasiran Expanded Indication

[ Price : $8.95]

Arrowhead Pharmaceuticals agrees to acquire an FDA Rare Pediatric Disease Priority Review Voucher from an undisclosed third party ...

Suggestions for FDA Draft Guidance on Some Oncology Studies

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Four stakeholders praise an FDA draft guidance on streamlining some oncology nonclinical safety studies and recommend improvements...

Dabur India CGMP Violations

[ Price : $8.95]

FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.

Quality System Issues at Koven Technologies

[ Price : $8.95]

FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketing of the Bidop 3 Doppler.

FDA Aims to Modernize Inspection Program

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FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance o...

FDA Finalizes Updated Device Human Factors Guidance

[ Price : $8.95]

FDA issues an updated final guidance entitled Applying Human Factors and Usability Engineering to Medical Devices.