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Sunshine Needed on Doc Drug Company Payments: Grassley

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Sen. Charles Grassley says the public needs to know when doctors and other providers are receiving payments from drug companies.

PreCert Webinar Materials Available

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CDRH releases software precertification webinar materials.

Court Denies Amgen Epogen Biosimilar Patent Appeal

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The Federal Circuit Appeals Court denies an Amgen request to compel discovery from Hospira on the cell culture medium Hospira uses...

FDA Clears Optovue Epithelial Mapping Software

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FDA clears an Optovue 510(k) for its epithelial thickness mapping software for quantitative measurements of the epithelial and str...

International Labs Recalls Mislabeled Pravastatin

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International Laboratories recalls one lot of pravastatin sodium tablets USP 40 mg packaged in bottles of 30 tablets due to mislab...

Guide on Expiry Dating for Unit Dose Repackaging

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Federal Register notice: FDA announces the availability of a revised draft guidance on Expiration Dating of Unit-Dose Repackaged S...

FDA Issues Medical Device Development Tool Guidance

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FDA publishes a final guidance on qualification of medical device development tools.

FDA Grants, Denies Prandin/Plavix Petition

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FDA grants a Public Citizen petition asking for labeling changes warning of a drug-drug interaction between Prandin and Plavix, bu...

ADA Wants OTC Oral Health Monograph Review

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The American Dental Association asks FDA to open a public review process to update five OTC oral health drug monographs.

China Joins ICH Drug Harmonization

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CDER Office of Strategic Programs director Theresa Mullin says China is reforming its drug approval program as part of its applica...