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FDA Draft Guidance on Use of Biomarker Galactomannan

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FDA releases a draft guidance on Qualification of Biomarker Galactomannan in studies of treatments of Invasive Aspergillosis that...

FDA Clears Centric Medical Tarsa-Link System

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FDA clears a Centric Medical 510(k) for its Tarsa-Link system for internal bone fixation of fractures, fusions, and osteotomies in...

Biogen Idec Confirms 1st PML Case with New Multiple Sclerosis Drug

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Biogen Idec confirms the first case of progressive multifocal leukoencephalopathy associated with a patient taking the companys ne...

FDA Supporting Online Rare Disease Study Tool

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CDER director Janet Woodcock says a new natural history online tool developed with the National Organization for Rare Diseases can...

Too Soon to Say if Device Review Process is Better: Report

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A California Healthcare Institute report sees some improvement in CDRH review times and processes, but says there is still more th...

FDA OKs Cytori ATHENA Cardiovascular Trial

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FDA notifies Cytori Therapeutics that it can continue enrollment in its ATHENA cardiovascular trials thanks to data and protocol a...

Guidance on Tissue Surgical Procedure Exceptions

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Federal Register Notice: FDA releases a draft guidance for tissue establishments and professionals: Same Surgical Procedure Except...

Teva Wants Generic QVAR to Have Dose Counter

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Teva asks FDA to require a dose counter in any generic form of its QVAR inhalation aerosol.

Regulatory Creep Seen in FDA Inspection Guidance

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Attorneys Jay Cormier and Anne Walsh say an FDA final guidance on company actions to limit or refuse an agency inspection contains...

Panel to Discuss Antibacterials for Serious Infections

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 12/4 to discuss clinical development programs and ...