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Compounding Facility Insanitary Conditions Guidance Out

[ Price : $8.95]

FDA issues a draft guidance on identifying and correcting insanitary conditions in drug compounding.

Info on Device Sterilization Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on shipment of devices for sterilization to the Office o...

Guidance on X-Ray Imaging Devices

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Federal Register Notice: FDA releases a draft guidance: Medical X-Ray Imaging Devices Conformance With IEC Standards.

Advocacy Groups Urge Consistent Biosimilar Naming

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Nine pharmacy-related advocacy groups tell key members of Congress that only USP should have authority over non-proprietary naming...

FDA to Update DTC Consumer Info

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FDA says it will conduct research to gain updated information on patient attitudes and behaviors involving direct-to-consumer ads ...

CDRH Discusses Symbols in Device Labeling as Rules Becomes Effective

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As a final rule becomes effective next month, CDRH discusses how device makers can use stand-alone symbols without adjacent text o...

FDA Awards Drug Quality Research Grant to LIU

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FDA awards a $2 million research grant to Long Island University to study variability in marketed drug products.

Boston Scientific Recalls 250 Lotus Valves Due to Delivery Error

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Boston Scientific recalls several lots of its Lotus Valve System due to breaks in the delivery systems release mechanism, which ha...

Teva Recalls 7 Lots of Amikacin Sulfate Antibiotic

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Teva Pharmaceuticals recalls seven lots of amikacin sulfate injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials...

Glaxo Gains Rx-to-OTC Switch for Flonase Sensimist

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FDA approves a GSK Consumer Healthcare NDA for Flonase Sensimist Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-t...