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FDA Issues Microbiological Countermeasures Guidance

[ Price : $8.95]

FDA publishes a guidance with recommendations for studies to establish the analytical and clinical performance of highly multiplex...

Court Upholds Ferring Lanham Case Dismissal

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The 3rd Circuit Appeals Court says a lower federal court correctly dismissed a Ferring petition for a preliminary injunction again...

Pfizer, Merck Join for Xalkor Trial

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Pfizer and Merck say they are collaborating in a Phase 1b trial of Pfizers Xalkor with Mercks pembrolizumab to treat patients with...

QS Problems Found at Childrens Medical Ventures

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FDAs Philadelphia District Office warns Childrens Medical Ventures/Philips Healthcare about Quality System violations in its manuf...

Kentz Product Inspection Finds QS Violations

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FDA warns Japans Suzuken Company about Quality System violations in its manufacturing of Holter monitor medical devices and electr...

CDER Draft Guidance on ANDA Controlled Correspondence

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CDER posts a draft guidance on Controlled Correspondence Related to Generic Drug Development that provides information on the proc...

QS, MDR Problems Found at Pharma Tech Solutions

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FDAs Los Angeles District Office warns Pharma Tech Solutions about Quality System and Medical Device Reporting regulation violatio...

FDA Grants Insys Therapeutics Orphan Drug Status

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FDA grants Insys Therapeutics an orphan drug designation to its pharmaceutical cannabidiol for treating glioblastoma multiforme.

St. Jude Resolves FDA Warning Letter

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FDA tells St. Jude Medical that issues cited in a 2009 Warning Letter about an inspection at the firms Plano, TX facility have bee...

10% Increase on Tropical Disease Priority Review Vouchers

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FDA raises by 10% the annual fee for using a tropical disease priority review voucher for fiscal year 2015.