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Quality Control Fears Prompt Letters to Four Dietary Supplement Makers

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:Drug GMP Report

Four supplement makers were hit with FDA warning letters March 22 over alleged quality control violations and related issues. Source: Drug GMP Report

Continue ReadingQuality Control Fears Prompt Letters to Four Dietary Supplement Makers

FDA Hits Compounders With Letters Over Sterility Issues, Misbranding

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:Drug GMP Report

Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Source: Drug GMP Report

Continue ReadingFDA Hits Compounders With Letters Over Sterility Issues, Misbranding

Expert: Focus on Data Consistency to Streamline Quality, Compliance

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:Drug GMP Report

The fragmented nature of the modern manufacturing sector necessitates focusing less on technology and more on integration, according to an industry expert. Source: Drug GMP Report

Continue ReadingExpert: Focus on Data Consistency to Streamline Quality, Compliance

Contract Manufacturer Gets Letter Over GMP Concerns, Labeling Issues

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:Drug GMP Report

A contract manufacturer is being hit with a warning letter over a slew of GMP and labeling violations. Source: Drug GMP Report

Continue ReadingContract Manufacturer Gets Letter Over GMP Concerns, Labeling Issues

Report: Surge in Data Integrity Citations Is Tied to Heightened Risk of Inspections

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:Drug GMP Report

There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause…

Continue ReadingReport: Surge in Data Integrity Citations Is Tied to Heightened Risk of Inspections

WuXi AppTec Lab Testing Division's Analytical And Stability Testing Facilities Passed FDA Inspection

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:BioPharma

  Life Sciences Jobs   ... Source: BioSpace

Continue ReadingWuXi AppTec Lab Testing Division's Analytical And Stability Testing Facilities Passed FDA Inspection

Sources Reveal Biogen is Exploring Sale of Hemophilia Assets

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:BioPharma

April 11, 2016By Mark Terry, BioSpace.com Breaking News Staff<BR... Source: BioSpace

Continue ReadingSources Reveal Biogen is Exploring Sale of Hemophilia Assets

<b>Regenerative Medicine Foundation</b> To Highlight Need For New Regulatory Pathway For Cell Therapies At April 12th Event

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:BioPharma

  Life Sciences Jobs   ... Source: BioSpace

Continue Reading<b>Regenerative Medicine Foundation</b> To Highlight Need For New Regulatory Pathway For Cell Therapies At April 12th Event

3 Depressed Biotechs that Investors with a Long-Term Perspective Should Buy Right Now

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:BioPharma

April 11, 2016By Alex Keown... Source: BioSpace

Continue Reading3 Depressed Biotechs that Investors with a Long-Term Perspective Should Buy Right Now

Valeant Board Of Directors Issues Statement On s Cooperation With Senate Committee On Aging

  • Post author:Sam
  • Post published:April 11, 2016
  • Post category:BioPharma

  Life Sciences Jobs   ... Source: BioSpace

Continue ReadingValeant Board Of Directors Issues Statement On s Cooperation With Senate Committee On Aging
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