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Clinical Hold on Sarepta Muscular Dystrophy Trial

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FDA places a clinical hold on a Sarepta Therapeutics Phase 1/2 Duchenne muscular dystrophy micro-dystrophin gene therapy trial due...

Probe 2 Unethical Minnesota Tests: Public Citizen

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Public Citizen calls on FDA and the HHS Office of Human Research Protections to investigate two clinical trials at a Minnesota hos...

Guide on Certain Drug Quality Assessments

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Federal Register notice: FDA makes available a draft guidance entitled Use of Liquids and/or Soft Foods as Vehicles for Drug Admin...

SCOTUS Will Hear Preemption Case Appeal

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Attorney Joe Hollingsworth says the Supreme Court should reverse a 3rd Circuit ruling that set a high evidentiary burden for drug ...

FDA Updates Safety Alert on Zoll LifeVest

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FDA updates an earlier safety alert that warned health professionals about Zoll Medicals Zoll LifeVest 4000 Wearable Cardioverter ...

Updated FDA Mobile Medical App List

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FDA releases an updated list of cleared or approved mobile medical applications.

Establishing Pharmacologic Class MAPP

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CDER issues a MAPP on establishing pharmacologic class for use in a drugs labeling Highlights section.

Agile to Pursue Twirla FDA Appeal

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Agile Therapeutics says it will appeal an ODE3 director decision denying its appeal of a complete response letter for its Twirla o...

PMA Approved for Magnetic Localization Biopsy Device

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FDA approves an Endomagnetics Inc. PMA for the Magtrace and Sentimag Magnetic Localization System, a device for guiding lymph node...

Gottlieb: More Focus on Modernizing Clinical Trials

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FDA commissioner Scott Gottlieb tells a House hearing that more focus is being placed on modernizing clinical trials.