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Revised Guide Gastroparesis Drug Development

[ Price : $8.95]

FDA revises a 2015 draft guidance on Gastroparesis: Clinical Evaluation of Drugs for Treatment.

Info Collection Extension for Device Accessories

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for its guidance on medical device accessories.

Drug Recalls Down, Units Up

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The Stericycle Recall Index says drug recalls are dropping but the number of recalled units is increasing, while medical device re...

FDA Inactivating Some Drug Listing Records

[ Price : $8.95]

FDA says it will start inactivating drug listing records that are improperly listed according to agency requirements.

QS Violations in Talon Inspection

[ Price : $8.95]

FDA warns Talon about Quality System and other violations in its production of Class 1 and 2 medical devices.

CGMP Violation in Emcure Inspection

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FDA warns Indias Emcure Pharmaceuticals about a CGMP issue in its production of finished pharmaceuticals.

No Higher Prostate Cancer Risk with Entacapone

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FDA says further study has indicated no increased risk of prostate cancer for users of Comtan or Stalevo to treat Parkinsons disea...

FDA Resists Criticism of Postmarketing Requirements: Study

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Dalhousie University professor Matthew Herder says FDA appears resigned to and resistant to criticism of its increasing regulatory...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Emcure Pharma, Lantech Pharma, Spectrum Laboratory Products and Tal...

DynoSense Cloud-based Vital Signs Monitor Cleared

[ Price : $8.95]

FDA clears a DynoSense 510(k) for its Vital Signs Measuring System, a cloud-based vital signs measuring and recording platform.