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CDRH Approves Dupont Transition Tyvek

[ Price : $8.95]

CDRH says Dupont Protection Technologies has demonstrated that its new (transition) Tyvek product is functionally equivalent to ex...

House Committee Continues Probe on FDA-inspected NIH Facility

[ Price : $8.95]

An ongoing House Energy and Commerce Committee investigation on management concerns at the NIH Clinical Center Pharmaceutical Deve...

Dissolution Testing Guidance Welcome

[ Price : $8.95]

Companies welcome an FDA guidance on dissolution testing and raise additional concerns.

FDA Centers Give Updates on Promotion Violations

[ Price : $8.95]

Presentations by CDER, CBER and CDRH advertising and promotion officials discuss current issues and violations observed at the age...

Justice Department Focusing on Individual Accountability: Official

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Justice Department Consumer Protection Branch assistant director Jill Furman says individual accountability for corporate wrongdoi...

FDA Grants Fast Track for S. Aureus Infection Therapy

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FDA grants fast track designation to Xbiotech for its monoclonal antibody therapy for treating all forms of Staphylococcus aureus ...

FDA Clears EarLens Contact Hearing Aid

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FDA clears an EarLens Corp. de novo petition for the EarLens Contact Hearing Device, a new hearing aid that uses a laser diode and...

Public Citizen Blasts NEJM Ethics

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Public Citizens Michael Carome says the New England Journal of Medicine breached its own ethics by publishing a commentary that gr...

Court Nixes DEA Scheduling Argument

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The DC federal court says that Eisai is not entitled to an extension of its marketing exclusivity for two drugs whose market entry...

Stakeholders Comment on Cyclosporine Letter

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Allergan says FDA should not think it can be talking with ANDA first applicants for generic Restasis because no generic drug compa...