1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

French Launch Fast-Track Clinical Trial Approval Scheme

 
• By Ian Schofield

Sponsors are being invited to trial a new fast-track system for authorizing clinical trials as part of French preparations for the new EU trial rules that are set to come into force in 2020.

Fast Track
France is running a fast-track clinical trial authorization scheme

French regulator ANSM has implemented a new system to speed up the authorization of clinical trials that offers two fast-track options for innovative new drugs and new trials of known substances.

Sponsors are invited to take part in the initial test run of the new system, which promises maximum processing times...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

More from R&D

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By Vibha Sharma

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 
• By Bridget Silverman

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

 
• By Michael McCaughan

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.