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Clinical / R&D

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Latest From Research & Development

Gene Therapy Guidances Will Focus On Specific Diseases, Gottlieb Says

US FDA's first such guidance will focus on hemophilia, commissioner tells Congress.

FDA Research & Development

Will ‘Transformative’ UK Life Sciences Sector Deal Help Offset The Brexit Effect?

The UK government has published its life sciences sector deal, which it says will allow the UK to respond to the challenges and opportunities of demographic change and pioneering research and development – although there is no mention of the “Brexit effect.”

Innovation Research & Development

EMA Points Out Shortfalls To Avoid When Seeking Novel Methodology Qualification

A new EMA checklist of “essential considerations” for the successful qualification of novel methodologies covers common issues that have compromised applications for qualification in the past.

Research & Development Research and Development Strategies

Breakthrough, Fast-Track Pathways Match Their Hype Of Reduced Development Times - JAMA

Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.

Review Pathway Drug Approval Standards

EMA To Change Rules After Ombudsman Clears Director Of Failure To Disclose Patents

The EMA says it has taken on board suggestions by the European Ombudsman for changes to its policy on staff declarations of interests, after the Ombudsman cleared the agency of failing to ensure its director general declared all relevant interests when he took up his post in 2011.

Compliance Europe

UK Industrial Strategy Offers ‘Substantial’ Life Science Investments Through New Sector Deal

The UK government has finally published its Industrial Strategy white paper, which includes a “sector deal” for the life sciences that promises “substantial” private and charitable sector investments.

Business Strategies Innovation
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