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Highlights of this issue
Highlights of this issue[1] U.
S.
FDA announces progress and initiatives
to promote pediatric drug development.
[2] The European Medicines Agency has initiated the first real-world evidence (RWE) studies under its DARWIN EU project
The U.
S.
FDA announces progress and initiatives to advance pediatric drug development
S.
FDA announces progress and initiatives to advance pediatric drug development
A few days ago, a number of US FDA officials jointly published an article on the FDA's official website, describing the FDA's progress and measures
in promoting the development of new drugs for children.
Increasing access to safe and effective drugs to treat children has been one of the FDA's
priorities.
Recently, the FDA reached an important milestone by adding evidence-based pediatric use information
to the labels of 1,000 drugs.
Going forward, FDA will work with stakeholders to advance treatment options for children in the following areas:
Accelerate the development of pediatric pharmaceutical products by partnering with developers to promote the use of innovative strategies
.
For example, the FDA recently issued draft guidance that provides recommendations
for using existing adult clinical trial data to support the development of pediatric drugs.
for using existing adult clinical trial data to support the development of pediatric drugs.
2.
Promote the participation of pediatric patients and their families in clinical trials and ensure that their input is integrated into the medical product development process
.
3.
Work with international regulatory agencies to ensure that children around the world can participate in clinics
that are rigorously designed and meet international regulatory, ethical and safety standards.
Related Links:
Related Links:
The European Medicines Agency has launched the first real-world evidence (RWE) studies under its DARWIN EU project
The European Medicines Agency has launched the first real-world evidence (RWE) studies under its DARWIN EU projectThe European Medicines Agency (EMA) has announced the selection of the first data partners
for its DARWIN EU project.
The full name of the DARWIN EU project is the EU Data Analytics and Real-World Considerations Network (Date
Analysis and Real-World Interrogation
Network）
。 Its goal is to establish a focal point
within the EU for timely and reliable real-world information on human medicines and vaccines.
DARWIN
The EU can provide EU countries with real-world evidence
of diseases, patient populations, drug use and performance.
of diseases, patient populations, drug use and performance.
The EMA simultaneously initiated three real-world studies, leveraging DARWIN
EU studies the epidemiology of rare blood cancers; Use of sodium valproate drugs; and antibiotic use (to provide insight into efforts to fight microbial resistance).
Related Links:
Related Links:
