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Comments Extended on New Dietary Ingredient Guidance

[ Price : $8.95]

Federal Register Notice: FDA extends the comment period on the draft guidance on new dietary ingredient notification for dietary s...

Guidance on New Tobacco Product Equivalence

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Federal Register Notice: FDA releases a draft guidance with frequently asked questions on demonstrating substantial equivalence of...

FDA Plans Health Professionals Conference

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Federal Register Notice: FDA plans a public conference 10/31 on how the agency and health professional organizations collaborate t...

Europeans Ratify FDA Generic Drug User Fee

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The European Fine Chemicals Group says it is backing FDAs legislative proposal for a generic drug user fee program.

Advisory Panel to Review Bisphosphonate Long-term Use

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An FDA advisory committee reviews safety issues associated with the long-term use of bisphosphonates for treating and preventing o...

Sagene Pharma Meets with FDA on Planned ED Drug

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Sagene Pharmaceuticals completes a pre-IND meeting with CDER reviewers to discuss the development plan for SPI-1972, a dual-action...

Panel to Discuss Vytorin/Zetia for Kidney Disease Patients

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 11/2 to discuss Merk/Schering-Plough...

Nexera to Amend 510(k) for SpectraShield 9500 Mask

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Nexera Medical says it plans to submit an amended 510(k) for the SpectraShield 9500 Surgical N95 Respirator for expanded antimicro...

NeurogesX sNDA for HIV-associated Pain

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NeurogesX files a supplemental NDA seeking to expand the label for Qutenza (capsaicin) 8% patch to include an indication for manag...

FDA Clears Medicis 510(k) for Liposonix System

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FDA clears a Medicis 510(k) for the Liposonix system for waist circumference reduction.