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Much of Higher Drug Spending Not Going to Companies: PhRMA

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A PhRMA-funded study says drug companies are not retaining much of the increased drug spending in the U.S.

Penumbra Expanded Indication for Aspiration Device

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FDA clears a Penumbra 510(k) for an expanded indication for its Indigo Aspiration System treating pulmonary embolisms.

Public Meeting on Modernizing FDA Data Strategy

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Federal Register notice: FDA announces a 3/27 public meeting entitled Modernizing FDAs Data Strategy.

Comments Extended on Certificates of Confidentiality Guide

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Federal Register notice: FDA extends until 1/24 the comment period for a draft guidance entitled Certificates of Confidentiality; ...

FDA Focus Group Info Collection Extension

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Federal Register notice: FDA seeks comments on an information collection extension on Focus Groups as Used by the Food and Drug Ad...

Comments Extended on Homeopathic Drug Guide

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Federal Register notice: FDA extends until 3/23 the comment period on a revised draft guidance entitled Drug Products Labeled as H...

Blueprint Rolling NDA for Lung Cancer Drug

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Blueprint Medicines begins a rolling NDA submission for pralsetinib after reporting top-line data from a pralsetinib study in pati...

Quality by Design Advantages Explained

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Recipharm staffers discuss the advantages of a quality by design approach to drug manufacturing.

FDA Officials Describe Staffing Challenges

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Calling FDAs regulatory system woefully out of date, a Heartland Institute post discusses recent agency executives comments about ...

Mercks Keytruda OKd for Bladder Cancer

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FDA approves Mercks Keytruda (pembrolizumab) for treating certain patients with non-muscle invasive bladder cancer.