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FDA Adapts Drug Development Tool Procedures to Adopt Alzheimer’s Simulation Tool

 
• By Jacqueline Fitton

FDA recently featured an Alzheimer’s Disease clinical trial simulation tool as another positive, but low-visibility, step toward improving the drug development pathway for the disease. The process for accepting the tool may be as important as the tool itself.

FDA Commissioner Margaret Hamburg posted an “FDA Voice” blog

piece in early April to praise the persistent advocacy efforts in the search for treatments for Alzheimer’s disease—if not the...

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More from Clinical Trials

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
• By Sue Sutter

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

More from R&D

Swissmedic Launches Pilot To Expedite Clinical Trial Applications

 
• By Anabel Costa-Ferreira

Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.

No ‘Doomsday’ For US Pharma Despite Political Uncertainties, EU Industry Chief Says

 
• By Eliza Slawther

While challenges in the US present an “incredible opportunity” for Europe, there is no “doomsday” happening there, Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says.

EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.