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The FDA director noted that the biomedical industry should focus on the development of therapies for chronic and addictive diseases
The FDA director noted that the biomedical industry should focus on the development of therapies for chronic and addictive diseasesRecently, DR.
While progress has been made in treating cancer and rare diseases, the decline in life expectancy in the United States has been largely driven by common chronic diseases, including cardiometabolic diseases, lung disease, kidney disease, and mental health problems
Declines in life expectancy are primarily driven by common chronic diseases, which include cardiometabolic diseases, lung disease, kidney disease, and mental health problems
The biomedical industry should re-examine the existing means of development and the focus of research and development for these diseases in order to develop more innovative therapies in these areas
Consortia, a consortium of patients, researchers, regulators and the medical product industry, is also an important part
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How can I improve the use of FDA Advisory Boards? Harvard experts made three suggestions
How can I improve the use of FDA Advisory Boards? Harvard experts made three suggestionsThe FDA Advisory Committee is comprised of external independent experts convened by the FDA to provide advice and recommendations to fda on science, technology, and policy-related matters
Recently, three scholars from Harvard University's Regulatory, Medical and Legal Program (PORTAL) published an article in the New England Journal of Medicine, saying that the FDA can adopt the following three initiatives to improve the use of FDA advisory committees:
1.
FDA may issue guidance explaining the specific conditions
Questions that need to be answered by the committee are published in advance before the advisory board meets, and for meetings involving approval of medical products, the FDA can design a standardized question structure
Establish a public mechanism to explain the reasons for
Related links: DOI: 10.
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First update in 14 years! The European Union publishes the latest GMP guidelines for the manufacture of sterile pharmaceuticals
First update in 14 years! The European Union publishes the latest GMP guidelines for the manufacture of sterile pharmaceuticalsA few days ago, the European Union issued the latest GMP guidelines
Manage the manufacture of sterile pharmaceutical products in the EU, as well as imported products
Most of this guidance will take effect on August 25,
Related links: https://health.
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Increased use of the European Medicines Agency's Clinical Trial Information System (CTIS).
Increased use of the European Medicines Agency's Clinical Trial Information System (CTIS).
The European Medicines Agency (EMA) has released a report
on the use of the new Clinical Trials Information System (CTIS), which was launched earlier this year.
CTIS is EMA's newly launched clinical trial filing, review and management system
.
Since January 31 this year, the EMA has encouraged all sponsors of clinical trials to submit clinical trial information
through this system.
.
Since January 31 this year, the EMA has encouraged all sponsors of clinical trials to submit clinical trial information
through this system.
As of July 31 this year, a total of 195 clinical trial applications have been submitted through CTIS, including 188 initial clinical trial applications, and a total of 43 clinical trials have been licensed
.
However, 224 clinical trial applications were still submitted through the previous EudraCT database during the
same period.
The EMA said the new CTIS system is conducive to improving information sharing, clinical trial transparency, helping joint decision-making in clinical trials and ensuring the security of
patient information.
It also enables clinical trial sponsors to conduct multiple clinical trials
simultaneously in the EU based on the same document.
patient information.
It also enables clinical trial sponsors to conduct multiple clinical trials
simultaneously in the EU based on the same document.
In January 2023, CTIS will replace EudraCT as a mandatory system
for clinical trial sponsors.
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