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Panel Recommends Randomized Trials for PI3K Inhibitors

[ Price : $8.95]

An FDA advisory panel unanimously votes to recommend that the agency require future approvals of phosphatidylinositol 3-kinase (PI...

Device RWE Partnership

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The National Evaluation System for Health Technology Coordinating Center is partnering with Aetion on a five-year strategic effort...

FDA Wants Comments on Opioid Disposal Proposal

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FDA solicits comments on a proposal to change the opioid REMS to provide postage-paid mail-back envelopes patients can use to retu...

AbbVie Abandons Alpha-Synuclein Parkinsons Program

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AbbVie walks away from a partnership with BioArctic AB to develop its portfolio of alpha-synuclein antibodies, including ABBV-0805...

Device Resilient Supply Chain Workshop Scheduled

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FDA launches a medical device resilient supply chain program and schedules a virtual public workshop on the effort.

FDA Drug Recall-Ready Tips

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A CDER podcast gives drug companies steps to follow to be better able to handle recalls quickly and efficiently.

2019 NARMS Integrated Summary Out

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FDA releases the 2019 National Antimicrobial Resistance Monitoring System Integrated Summary showing that salmonella resistance in...

American Regent Production Supervisor Sentenced

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The Justice Department says an American Regent drug production supervisor has been sentenced to jail time and payment of restituti...

Study on Physician Use of Off-label Unsupportive Data

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A new study about the influence of data disclosures on physician decisions about off-label uses suggests that there is limited awa...

FDA Needs Procedures for Reporting Political Interference: GAO

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A new Government Accountability Office report recommends that FDA and other HHS agencies develop procedures for reporting and addr...