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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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