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CDER Promotes Deputy Slack to Head Strategic Programs

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CDER promotes Office of Strategic Programs deputy director Mary Slack to permanent director.

FDA Tells 21 Web Sites to Stop Selling Opioids

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FDA tells four more online networks operating 21 Web sites to stop selling unapproved and misbranded versions of opioid drugs.

Recognize Auryxia Regulatory Exclusivity: Keryx Petition

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Keryx asks FDA to recognize two forms of exclusivity for its Auryxia ferric citrate drug.

FDA Clears Add-on to Ceterix Orthopedics Meniscal Repair

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FDA clears a Ceterix Orthopedics 510(k) for an added feature to the NovoStitch Pro Meniscal Repair System a size 0 suture cartrid...

Haemonetics Recalls 10 Lots of Leukotrap RC System

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Haemonetics recalls 10 lots of their Leukotrap RC System with RC2D Filter, intended for collecting whole blood and preparation of ...

False, Misleading EstroGel Sell Sheet: OPDP

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CDERs Office of Prescription Drug Promotion says a professional sell sheet for Ascends EstroGel contains false and misleading clai...

Mixed Reaction to Mexico Biological Drug Trade Deal

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Representatives of innovator and generic drug companies disagree on the value of a 10-year drug exclusivity provision in the trade...

End Unethical, Reckless NIH Sepsis Trial: Public Citizen

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Public Citizens call for an end to the NIH-funded CLOVERS trial it says has serious regulatory and ethical lapses.

Appeals Court Backs Eyedrop Suit Dismissal

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The 1st Circuit Appeals Court backs a federal district court decision that a suit seeking to use state laws to force prescription ...

Reflection Biotechnologies Orphan Drug Designation

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FDA grants Reflection Biotechnologies an orphan drug designation for RBIO-101, an adeno-associated virus gene therapy product for ...