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FDA OKs Sigma-Tau Pharma Cystaran Ophthalmic Therapeutic

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FDA approves Sigma Tau Pharmaceuticals Cystaran 0.44%, a topical ophthalmic therapeutic for treating corneal cystine crystal accum...

FDA Shuts Down 4,100 Illegal Internet Pharmacies

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FDA, in partnership with international regulatory and law enforcement agencies, takes enforcement actions this week against more t...

FDA Clears Covidien Respiratory Monitor

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FDA clears a Covidien 510(k) for the Nellcor Bedside Respiratory Patient Monitoring System.

Refuse to Accept Guidance Needs Changes: Comments

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Medical device manufacturers and advocacy groups suggest changes and clarifications they believe are needed in FDAs draft guidance...

Apotex Sues FDA Over Compliance Status Report Failure

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Apotex files suit against FDA charging that the agencys alleged failure to record the compliance status of its manufacturing facil...

FDA Iron Sucrose Guidance Challenged

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Luitpold Pharmaceuticals and four patient advocacy groups question an FDA draft guidance on determining bioequivalence for generic...

Public Citizen Wants Boxed Warnings for Hypertension Drugs

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Public Citizen petitions FDA to require a Boxed Warning and Medication Guide for 19 hypertension drugs.

Drug Compounder Was Warned by FDA 6 Years Ago

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FDA Webview learns that a drug compounding pharmacy at the center of a fatal meningitis outbreak traced back to steroid injections...

FDA Should Reconsider Classification Guidance: Attorney

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Hyman, Phelps & McNamara attorney Jeffrey Gibbs asks FDA to reconsider its draft guidance on Classification of Products as Drugs a...

FDA Safety and Innovation Act Fell Short: Professors

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Harvard Medical School professors Daniel Kramer and Aaron Kesselheim say the new FDA Safety and Innovations Act could have taken m...