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How Well is FDA Protecting the Population?

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Consulting editor John Scharmann considers the regulatory issues presented by increasing imports of drugs and drug components in a...

Spectrum Files IND for Hyperphosphatemia Therapy

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Spectrum Pharmaceuticals submits an IND application for SPI-014, a second-generation lanthanum-based nanoparticle phosphate bindin...

FDA Briefing Documents Encouraging for Affymax Anemia Drug

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FDA advisory committee briefing documents show that an Affymax anemia drug was as effective as currently used epoetin or darbepoet...

5 Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that G.D. Searles Demulen tablet and Wyeths Triphasil were not withdrawn for reasons of sa...

FDA Cancels Dispute Panel Meeting on Ethicon Sedasys PMA

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Federal Register Notice: FDA is canceling a 12/14 dispute resolution panel meeting scheduled to discuss CDRHs denial of Ethicon En...

Roche Files 510(k) for Elecsys Vitamin D Test

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Roche files a 510(k) application with FDA for its Elecsys vitamin D test, a total vitamin D assay for use on its laboratory analyz...

CDER, Shire Agree on Trials to Keep Midodrine on Market

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CDER and Shire reach an agreement for the company to conduct additional clinical trials to confirm the clinical benefit of ProAmat...

Clinical Data Shows Better Survival with Pfizers Axitnib

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In advance of an advisory panel meeting, clinical data show improved progression-free survival for advanced renal cell carcinoma p...

FDA Confirms Bioequivalence Standards for Asacol

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FDA confirms that it continues to recommend that potential generic Asacol and Asacol HD (mesalamine) applicants should demonstrate...

Guidance on Classification of Pharmaceutical Co-crystals

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Federal Register Notice: FDA releases a draft guidance on regulatory classification of pharmaceutical co-crystals.