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Sep 01, 2014


 
Announcing Final Guidance on FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
The Food and Drug Administration (FDA) has recently issued a final guidance document

The final guidance describes the FDA's decision-making and communications regarding applications from companies that want to conduct medical device clinical trials in the US. It also describes more flexible options for clinical study approvals that allow clinical studies to begin sooner while ensuring patient protections.
The final guidance outlines:

  • Processes to allow more efficient study enrollment
  • Provides information regarding the FDA €™s decision-making processes to improve predictability of the regulatory process
  • Introduces communication intended to improve the transparency of FDA €™s decision-making process
More details online



European Medicines Agency publishes booklet on European regulatory system for medicines
The European Medicines Agency (EMA) today published an illustrated leaflet explaining how the European regulatory system for medicines operates.

The European Medicines Agency (EMA) today published an illustrated leaflet explaining how the European regulatory system for medicines operates. It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network - a partnership between the European Commission, the 50 medicines regulatory authorities in the EU and the European Economic Area (EEA), and the EMA - works to ensure that patients in the EU have access to safe and effective medicines.

View the illustrated leaflet



New Release on ClinicalTrials.gov PRS Test site
ClinicalTrials.gov released a new version of the Protocol Registration and Results System (PRS) Test site.

ClinicalTrials.gov released a new version of the Protocol Registration and Results System (PRS) Test site (https://prstest.nlm.nih.gov) on August 28, 2014. These updates are planned to be implemented in the PRS on September 17, 2014. The first thing you may notice is the new name, which better reflects the dual functions it serves. The updates are user interface improvements primarily focused on the process for entering and submitting data for a single record. We've also made new Help resources available. The updates do not involve changes to data elements, but data elements were re-ordered to match the new PRS workflow and new versions of the data element definitions documents will be made available. Use the What's New link on the Main Menu for a complete description of all the changes.
ClinicalTrials.gov encourages users to test the updates and to submit feedback on any issues encountered to register@clinicaltrials.gov. One can also use this email if one needs assistance gaining access to the PRS Test System.

View the site here


 

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