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Authors Defend 21st Century Cures Concerns

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Authors Aaron Kesselheim and Jerry Avorn respond to critics of some of their criticisms of the 21st Century Cures Act.

FDA Orders New Studies on Concordias Kayexalate

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FDA orders Concordia Pharmaceuticals to conduct postmarketing studies to investigate Kayexalates (sodium polystyrene sulfonate) po...

Two Groups Back Pacira Free Speech Bid

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Two drug industry trade groups tell a New York federal court they support Paciras efforts to make truthful and non-misleading stat...

Guilty Pleas in Drug Diversion Scheme

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The Justice Department says two men have pleaded guilty as part of an ongoing investigation of a major drug diversion operation.

FDA Approves Merrimack Pancreatic Cancer Drug

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FDA approves a Merrimack Pharmaceuticals NDA for Onivyde (irinotecan liposome injection) for use in combination with fluorouracil ...

Zafgen Closing Beloranib Trials After Patient Death

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Zafgen decides to close the randomized portion of its Phase 3 trial of beloranib in patients with Prader-Willi syndrome after repo...

Guidance on Package Types for Injectable Products

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Federal Register Notice: FDA releases a draft guidance: Selection of the Appropriate Package Type Terms and Recommendations for La...

DoJ Using Healthcare Data for Marketing Cases

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Principal deputy assistant attorney general Benjamin Mizer says the department is making greater use of healthcare data in its sal...

Insightec Files PMA for Exablate Neuro

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Insightec files a PMA for the Exablate Neuro focused ultrasound ablation device for treating essential tremor.

FDA Safety Alert on AbbVie Hepatitis C Drugs

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FDA warns that hepatitis C treatments Viekira Pak and Technivie, both made by AbbVie, can cause serious liver injury in patients w...