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Guidance on Tobacco Warning Plans

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on the submission of warning plans for cigarettes and smokeless tobacco pro...

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...

CDRH Letter to Industry on Speeding Import Entries

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A CDRH letter to industry provides recommendations to help ease the FDA import entry review process for medical and non-medical ra...

Panel Backs J&J's Stroke Drug Xarelto

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An FDA advisory committee votes to recommend approval of a Janssen Pharmaceuticals NDA for its investigational drug Xarelto (rivar...

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.

8 Drug Companies Spend $220 Million on Physician Speakers

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A ProPublica analysis finds that eight drug companies paid physicians more than $220 million last year to act as promotional speak...