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FDA Priority Review for Takedas Ixazomib

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FDA grants Takeda Pharmaceutical Co. a priority review for its NDA for ixazomib, the first investigational oral proteasome inhibit...

Biologic Naming Questions Remain

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Ropes & Gray attorneys outline the FDA draft guidance on biosimilar naming and questions that are left unanswered pending public c...

Pacira Seeks 1st Amendment Injunction Against FDA

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Pacira asks a New York federal court to overturn an FDA Warning Letter preventing the company from making truthful, non-misleading...

FDA Approves New Havens Durlaza

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FDA approves a New Haven Pharmaceuticals NDA for Durlaza (aspirin), a 24-hour, extended release capsule (162.5mg) formulation for ...

CVM Announces Export Certificate Fees

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CVM announces fees for animal food and feed ingredients export certificates effective 10/1.

Royal Phillips Spectral Diagnostic Suite Cleared

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FDA clears a Royal Phillips 510(k) to market the Spectral Diagnostic Suite, a set of visualization and analysis tools designed for...

Guidance on Syphilis Screening Tests for HCT/P Donors

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Federal Register Notice: FDA releases a guidance: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular...

FDA Corrects Notice on Critical Path Workshop

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Federal Register Notice: FDA corrects Web links for registration for a scientific workshop co-sponsored by FDA and the Coalition A...

FDA Expands Warning on Drugs in Becton-Dickinson Syringes

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FDA expands an alert on compounded or repackaged drugs stored in Becton-Dickinson syringes to additional sizes because interaction...

FDA Approves Tandem Diabetes PMA for Insulin Pump

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FDA approves a Tandem Diabetes Care PMA for the t:slim G4 Insulin Pump, a touch-screen pump with continuous glucose monitoring int...