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No Increased Budget for IT Modernization: Abernethy

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FDA principal deputy commissioner Amy Abernethy tells a Webinar that the agencys large-scale and ambitious plan to modernize its i...

Teleflex Comfort Flo Recall is Class 1

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FDA says a Teleflex Medical recall of Comfort Flo humidification systems is Class 1.

Priority Review for BioMarin Gene Therapy

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FDA grants priority review to a BioMarin investigational gene therapy for hemophilia A.

Baudax Bio NDA for Anjeso Approved

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FDA approves a Baudax Bio NDA for Anjeso (meloxicam injection), indicated for managing moderate to severe pain.

Comments Reopened on Animal Drug Compounding

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Federal Register notice: FDA reopens the comment period for an 11/20/2019 notice seeking comments on Guidance for Industry #256 C...

Nonclinical Evaluation of Immunotoxicity Guide

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Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Safety Evaluation of the Immunotoxic Potential ...

Cabiralizumab Phase 2 Trial Misses Endpoint

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Bristol-Myers Squibb says a Phase 2 trial of cabiralizumab in patients with advanced pancreatic cancer did not meet its primary en...

FDA Late in Removing Mesh Products: Study

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University researchers say that FDA was late in ordering mesh implants used in pelvic organ prolapse from the market, possibly due...

Collaborative Review of Scientific Pharmacogenetic Info

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CDRH and CDER launch a new Web resource to provide the current science on gene-drug associations.

Grassley Predicts Drug Price Bill by May 20

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Sen. Grassley predicts that his bipartisan drug pricing legislation will pass by 5/20.