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FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
The U.S. Food and Drug Administration (FDA) announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and heal...

FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient
The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enablin...

NexMed Receives FDA Response for ED Product
NexMed announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA)...

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin
Cell Therapeutics has announced that the Company has scheduled a meeting with the U.S. Food and Drug Administration (FDA) in September to discuss the ...

FDA Clears Osmetech's Warfarin Sensitivity Test and New eSensor XT-8 Platform
Osmetech has announced that it has received 510(k) clearance from the US Food & Drug Administration ('FDA') for its eSensor Warfarin Sensitivity Test ...

NeuroHealing Pharmaceuticals Receives Grant from the FDA Office of Orphan Drugs for Clinical Development of NH001
NeuroHealing Pharmaceuticals, a company developing products for individuals with chronic brain injuries, announced that the Food and Drug Administrati...

St. Jude Medical Announces FDA Approval of Wireless Transmitter to Monitor Patients' Implanted Cardiac Devices
St. Jude Medical announced U.S. Food and Drug Administration (FDA) approval of the Merlin@home transmitter, an RF wireless technology that remotely mo...

FDA Accepts Genta's NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia
Genta has announced that the Food and Drug Administration (FDA) has accepted the Company's amendment to its New Drug Application (NDA) for Genasense(R...

FDA Approves Energex Systems, Non-Drug Therapy For HIV Research
Energex Systems, announced that it has been granted approval from the Federal Food and Drug Administration (FDA) to utilize its experimental HemoModul...

FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be a...

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