Drug Trials FDA Approval Medicine 
Advarra
AUGUST 16, 2022
Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.
Delveinsight
AUGUST 13, 2021
The conduct of trials was not possible due to the risk of catching coronavirus. At the same time, some pharmaceuticals, due to the priority to develop therapeutics and preventive medicines for COVID-19, had put ongoing trials for other indications at the backfoot.
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FDA Law Blog
MAY 3, 2021
for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). National Library of Medicine.
XTalks
AUGUST 4, 2022
This started back in 1993 when the FDA established guidelines to increase diversity by gender and race/ethnicity of participants in clinical trials that were contributing to new drug approvals. An analysis of trials that supported FDA approvals of new cardiometabolic drugs from 2008 to 2017.
FDA Law Blog
MAY 3, 2021
for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). National Library of Medicine.
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