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FDA OKs Lantheus Ultrasound Contrast Agent Labeling Changes

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FDA approves Lantheus Medical Imagings proposed labeling changes removing statements from the warning sections of the labeling for...

FDA Delays Dapagliflozin PDUFA Action Date

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FDA delays for three months its PDUFA action date for Bristol-Myers Squibb/AstraZenecas dapagliflozin NDA for treating Type 2 diab...

Harmonization Needs Industrys Collective Persuasion: FDAer

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A senior FDA official opines that it will probably take collective persuasion from industry to bring international harmonization t...

Public Citizen Wants Tygacil Boxed Warning

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Public Citizen calls on FDA to add a Boxed Warning of increased mortality risk to the labeling for Tygacil.

FDA Grants $2 Million for Regulatory Science Centers

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FDA awards $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation.

Pay-for-delay Continues to Grow: FTC

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The Federal Trade Commission says there were almost as many potential pay-for-delay patent settlements in the last two fiscal year...

Stevens Case Dismissal Helps In-house Counsel: Attorneys

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Lane Powell attorneys say the dismissal of felony obstruction charges against former GSK associate general counsel Lauren Stevens ...

Good Outcome When Extrapolating Data for Pediatrics: FDA

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FDA says that extrapolating efficacy data from studies conducted in adults to the pediatric population can help increase the numbe...

Annual Status Report MAPP Out

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CDER issues a MAPP on how staff will verify applicants reported status on postmarketing requirements and commitments.

Group Cautions FDA on Restricting Access to Diagnostic Devices

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The Association for Molecular Pathology expresses concern in comments to an FDA draft guidance on in vitro companion diagnostic de...