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Updated Draft Guidance Describes Process for Dispute Resolutions for Drug Products

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The US Food and Drug Administration (FDA) has released a new draft guidance that describes the process by which those in the biopharmaceutical industry can initiate and elevate disputes regarding drug Read More...

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CDRH Report Shows Steady Increase in Complaints, but Few Clear Reasons Why

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The Center for Devices and Radiological Health's (CDRH) ombudsman has released a report indicating that complaints made against the center and its employees have increased for a fourth straight Read More...

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European Ombudsman Chides EMA for Transparency Problems

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A report from the European Ombudsman calls on the European Medicines Agency (EMA) to increase the transparency surrounding its pediatric medicines testing requirements after finding an inconsistent Read More...

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CDER Ombudsman: Smaller Companies Feel Confusion, Pinch of Regulations

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A report released by the Ombudsman’s Office of the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) for 2011 says smaller companies are contacting it more because they Read More...

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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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Updated Draft Guidance Describes Process for Dispute Resolutions for Drug Products

CDRH Report Shows Steady Increase in Complaints, but Few Clear Reasons Why

European Ombudsman Chides EMA for Transparency Problems

CDER Ombudsman: Smaller Companies Feel Confusion, Pinch of Regulations

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