Search Results for 'fda'

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• Bio News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News | R&D
  

  Fibrocell Science Awarded $1.4M FDA Orphan Grant

  For the continued clinical development of FCX-007, the Company’s gene therapy candidate for the treatment of RDEB

  09.25.18
  

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• Bio News | Facilities | Fill/Finish | Industry News | Trials & Filings
  

  Symbiosis Secures FDA Approval

  For its viral vector manufacturing fill/finish process at its biologics manufacturing facility located in Scotland, UK

  09.24.18
  

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• APIs | Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
  

  Novasep Announces Successful FDA Inspection

  At its API development and manufacturing site in Chasse-sur-Rhône, France

  08.27.18
  

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• Bio News | cGMP Manufacture | Facilities | Industry News | Process Development | R&D | Trials & Filings
  

  Seqirus Receives FDA Approval for New Mfg. Process

  Will enable Seqirus to double current production levels of FLUCELVAX® QUADRIVALENT for supply in the 2019/20 flu season

  08.24.18
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
  

  FDA Approves Grifols' Facility for Production of Recombinant Proteins

  New facility, equipment, and automation systems ensure reliable production of antigens for blood supply safety

  08.20.18
  

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• Bio News | Clinical Trials | Drug Development | Drug Discovery | Industry News | Trials & Filings
  

  FDA Grants Harmony Breakthrough Therapy & Fast Track Designations

  For its investigational product, pitolisant, for the treatment of narcolepsy

  05.21.18
  

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• Peter Stein to Deliver FDA Keynote Presentation

  Dr. Stein joined FDA in late 2016 as the deputy director at the OND, CDER

  04.18.18
  

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• cGMP Manufacture | Industry News | Regulatory Affairs
  

  FDA Releases FY 2018 GDUFA Rates

  The FY 2018 fee represents a significant drop from FY17's FDF fee of $258,646

  08.28.17
  

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• Regulatory Affairs
  

  The FDA and Metrics

  The Agency and industry continue to work together to achieve FDA’s objectives

  David Lonza, Lachman Consultant Services, Inc. 05.09.17
  

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• QA/QC | Regulatory Affairs
  

  FDA’s Quality Agreements Guidance

  Evaluation of FDA’s recently issued Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry

  Paul Mason, Ph.D., Director of Lachman Consultant Services, Inc. 01.26.17
  

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• APIs | Extractables and Leachables | Facilities | GMPs/GCPs | Information Technology | Inspections | Methods Development | Process Development | QA/QC | Regulatory Affairs | Risk Management | Supply Chain | Validation
  

  FDA’s Quality Agreement Guidance Vs. EMA’s cGMP Regulations

  Can you comply with both?

  John Avellanet, Cerulean Associates LLC 10.09.13
  

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• CBE 30

  Similar to Changes Being Effected (CBE). A filing with the FDA to gain approval of a moderate change, i.e., a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as…

  03.25.13
  

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