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<b>Blue Ribbon</b> Highlights Session Recognizes Best Posters From 21st <b>International Congress Of Parkinson???s Disease And Movement Disorders</b>

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:BioPharma

  Life Sciences Jobs   ... Source: BioSpace

Continue Reading<b>Blue Ribbon</b> Highlights Session Recognizes Best Posters From 21st <b>International Congress Of Parkinson???s Disease And Movement Disorders</b>

Intuitive Surgical Reports New Employee Option Grants For June 2017

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:BioPharma

  Life Sciences Jobs   ... Source: BioSpace

Continue ReadingIntuitive Surgical Reports New Employee Option Grants For June 2017

KPH Healthcare Adds Three Companies to Generics Drug Price-Fixing Lawsuits

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:Drug Industry Daily

A pharmacy chain operator that brought antitrust class action lawsuits against more than a dozen generics manufacturers earlier this week has added three more — Actavis Holdco, Lannett and Epic…

Continue ReadingKPH Healthcare Adds Three Companies to Generics Drug Price-Fixing Lawsuits

ABPI Reprimands Astellas UK and Gedeon Richter for Publishing Inaccurate Information

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:Drug Industry Daily

The Association of the British Pharmaceutical Industry will run advertisements later this month in three medical journals listing Astellas UK and Gedeon Richter as in breach of the ABPI’s Code…

Continue ReadingABPI Reprimands Astellas UK and Gedeon Richter for Publishing Inaccurate Information

FDA Planning Phased Transition to New Cures Act Drug Development Tool Qualification Scheme

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:Drug Industry Daily

The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers,…

Continue ReadingFDA Planning Phased Transition to New Cures Act Drug Development Tool Qualification Scheme

FDA Requests Endo Remove Opioid Painkiller Opana ER From the Market After Reports of Abuse

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:Drug Industry Daily

The FDA requested that Endo Pharmaceuticals voluntarily remove its opioid painkiller Opana ER from the market, saying its benefits may no longer outweigh its risks of abuse — the first…

Continue ReadingFDA Requests Endo Remove Opioid Painkiller Opana ER From the Market After Reports of Abuse

Medical Device Single Audit Program Gains Momentum

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:The GMP Letter

Companies most likely to benefit from the Medical Device Single Audit Program will include those selling products in Canada, along with manufacturers of finished medical devices and high-risk devices, said…

Continue ReadingMedical Device Single Audit Program Gains Momentum

Warning Letter Roundup: FDA Hits Devicemakers Over GMPs, Validations

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:The GMP Letter

The FDA issued warnings to three device manufacturers for failures in GMPs, validations, MDRs, and other quality-related issues. Source: The GMP Letter

Continue ReadingWarning Letter Roundup: FDA Hits Devicemakers Over GMPs, Validations

483 Roundup: FDA Cites Four Firms for Reporting, Documentation

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:The GMP Letter

Repro-Med Systems in Chester, N.Y. failed to submit a report to the FDA on steps taken to reduce a health risk posed from a device, inspectors found during a late…

Continue Reading483 Roundup: FDA Cites Four Firms for Reporting, Documentation

How to Detect Trends in Medical Device Complaints

  • Post author:Sam
  • Post published:June 8, 2017
  • Post category:The GMP Letter

Some devicemakers can be slow to recognize trends in medical device complaints. It’s not enough to have a solid complaint handling system when regulators expect you to learn something from…

Continue ReadingHow to Detect Trends in Medical Device Complaints
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