Clinical Trials


Korea ‘Guide’ Program To Speed Select Innovative Products To Market

 
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In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.

US FDA Says Restored Webpages Do Not Reflect ‘Biological Reality’

 
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Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."

EU Funding Offer For Scientific Studies That Will Inform Regulatory Practice

 

The European Medicines Agency is looking for researchers to conduct scientific studies that address specific regulatory concerns, such as the development of innovative clinical trial designs or validation of novel manufacturing methods.

Switzerland Updates Decentralized Trials Paper To Align With EU, US Standards

 

Companies looking to conduct decentralized clinical trials in Europe can now easily see how Switzerland’s rules and processes compare with those of EU member states.