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Reps. Concerned About Generic Drug Labeling Proposal

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Reps. Israel and Bishop says an FDA proposed rule changing generic drug labels could severely harm the industry.

Custom Device Exemption Guidance

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Federal Register Notice: FDA releases a guidance: Custom Device Exemption.

Unreasonable Patients Spur LASIK Harm Reports: FDA Contractor

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A U.S. Navy contractor to FDA who studied quality of life issues in LASIK patients publishes an article saying unreasonable expect...

Shire Settles False Claims Case for $56.5 Million

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Shire Pharmaceuticals agrees to pay the U.S. government $56.5 million to resolve civil allegations that it violated the False Clai...

More Detail, Clarity Sought in Biosimilarity Guidance

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The International Consortium for Innovation and Quality calls on FDA to add more detail and clarity to a draft guidance on clinica...

Veterinary ICH Guidance on Blood Level Bioequivalence

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Federal Register Notice: FDA is making available a draft guidance on harmonizing the data recommendations associated with in vivo ...

FDA Clears Expanded Nova Glucose Meter Indication

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FDA clears an expanded indication for Nova Biomedicals StatStrip glucose hospital meter system for use with critically ill patient...

CDER Guidance Coming on Quality Metrics Initiative

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CDER says it will publish a draft guidance on its Quality Metrics Initiative by the end of the year.

Coalition Seeks Hamburg Firing Over Opioid Approvals

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A coalition of anti-opioid addiction advocates asks HHS secretary Sylvia Burwell to fire FDA commissioner Margaret Hamburg over th...

Fluoroscopic Equipment Guidance Out

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FDA issues a draft guidance to say that it does not intend to consider whether firms that provide a declaration of conformity and ...