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Comments Sought on PDUFA Workload Adjuster

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a consulting firms assessment of the Prescription Drug User Fee Act Workload Adjust...

Comments Reopened on BE Assessment of Veterinary Drugs

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on in vitro methods used to assess bioequivalence of nonsystemically absor...

ICH Guidance on Efficacy Component in CTD Format

[ Price : $8.95]

Federal Register Notice: FDA releases a draft ICH guidance: M4E(R2): The CTD Efficacy.

Amicus Delays Fabry Disease NDA Due to FDA Data Request

[ Price : $8.95]

Amicus Therapeutics delays its plans to submit an NDA by the end of the year for migalastat, indicated for treating Fabry disease,...

RegenxBio Rare Disease Therapy Wins Orphan Status

[ Price : $8.95]

FDA grants RegenxBio an orphan drug designation for RGX-111 for treating mucopolysaccharidosis Type 1.

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

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

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...

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...