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Tropical Disease Priority Review Fee is $2.46 Million

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate for using a tropical disease priority review voucher for fiscal year 2019 $2....

Ultrasound Cyclodestructive Device Reclassification Proposed

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Federal Register notice: FDA issues a proposed order to reclassify the ultrasound cyclodestructive device, a postamendments Class ...

FDA Clears Synergy Biomedicals Biosphere Flex

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FDA clears a Synergy Biomedical 510(k) for the Biosphere Flex, a strip-format bone graft product made of porous, bioactive glass.

Factors in Pivotal Trial Costs

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Researchers say pivotal clinical trials often are not the main reason for the high cost of drug development.

CGMP Violations at Wilson Medicine Co.

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FDA warns Indias Wilson Medicine Co. about CGMP violations in the production of finished drugs.

FDA Publishes 3 Drug Compounding Guidances

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FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of r...

Info Collection Extension For Generic Drug Cover Sheet

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Federal Register notice: FDA announces an opportunity for public comment on an information collection extension entitled Generic D...

CDER Drug Inspection Common Deficiencies

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CDER Office of Process and Facilities branch chief Ying Zhang outlines common issues and deficiencies cited during pre‐appro...

Preempt State Liability for Branded Drug Label: WLF

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Washington Legal Foundation urges the Supreme Court to reject a 3rd Circuit Court of Appeals ruling that a preemption case should ...

CID Guidance, MAPPs Coming: Price

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CDER Division of Biometrics IV director Dionne Price outlines ways in which FDA will promote use of complex innovative trial desig...