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WLF Urges FDA to Replace Guidances with Rulemaking

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The Washington Legal Foundation urges FDA to replace all older guidances with formal regulations that undergo a notice-and-comment...

Comment Period Extended on Synthetic Peptide Guide

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Federal Register notice: FDA extends the comment period on a 10/3 draft guidance entitled ANDAs for Certain Highly Purified Synthe...

Gottlieb: Science Contributing to Inflection Point in Medicine

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FDA commissioner Scott Gottlieb says that across multiple science fields, we stand at an inflection point in medicine where new t...

Avanir Paid Disciplined Doctors to Promote Nudexta: CNN

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CNN says Avanir has paid some doctors facing disciplinary measures or criminal charges to promote its Nudexta.

Drug Spending Increase Lower than Last 2 Years: Report

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Federal actuaries say the annual increase in spending on prescription drugs nationally was lower in 2016 than in the previous two ...

FDA Expands Digital Health Efforts: Gottlieb

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FDA commissioner Scott Gottlieb announces three new guidances to expand the agencys digital health efforts under the 21st Century ...

Duke Launches Real-World Evidence Collaborative

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The Duke Margolis Center for Health Policy announces a new Real-World Evidence Collaborative to support FDA in meeting real-world ...

Bayer Rebuts DeLauro Complaint on Essure Study

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Bayer vice president Steven Immergut disputes a complaint by Rep. Rosa DeLauro (D-CT) that the company has enrolled only one patie...

Guide on Pediatric Rare Disease Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Pediatric Rare Diseases A Collaborative Approach for Drug ...

FDA Urges Primus Pharma to Recall Suspect Product

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FDA asks Primus Pharmaceuticals (Scottsdale, AZ) to recall Limbrel, a capsule marketed to manage the metabolic processes associate...