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Court Rejects FDA Affiliate Interpretation for User Fee Waiver

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An Illinois federal court rejects FDAs interpretation of the word affiliate in determining that it does not have to grant an NDA f...

Spinal Restoration and FDA Agree on Trial Details

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Spinal Restoration and FDA reach agreement on a Special Protocol Assessment for the design of a Phase 3 study involving the Biosta...

FDA Detaining Swedish Ophthalmic Viscoelastic Devices

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FDA says it is detaining without physical examination Advanced Medical Optics Uppsala Abs Healon D ophthalmic viscoelastic devices...

FDA Opens Mexico City Office

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FDA opens a new Mexico City office to foster further collaboration with the Mexican government.

FDA Approves Generic Aricept for Alzheimers Dementia

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FDA approves Mutual Pharmaceuticals generic form of Aricept orally disintegrating tablets.

FDA OKs Boehringer NADA for Diabetic Cats

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Federal Register Final rule: FDA approves a Boehringer Ingelheim Vetmedica NADA for veterinary prescription use of protamine zinc ...

FDA Clears Dilon Diagnostics Lesion-localization System

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FDA clears a Dilon Diagnostics 510(k) clearance for the GammaLMc lesion-localization system for molecular imaging biopsy guidance.

FDA OKs Lillys Zyprexa Relprevv for Schizophrenia

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FDA approves Eli Lillys Zyprexa Relprevv for extended release injectable suspension for treating schizophrenia in adults.

Alexza Submits Staccato NDA

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Alexza Pharmaceuticals submits an NDA to FDA for its Staccato loxapine inhalation drug for treating agitation in patients with sch...

Animal Drug Regs Change Sponsor to Intervet

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Federal Register Final rule: FDA amends the animal drug regulations to show a change of sponsor name and address from Schering-Plo...