
Study Compares Regulatory Review at FDA with EMA
A new study in NEJM compares the regulatory review processes of FDA and EMA.
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The median total review time for therapeutic agents during this period, according to the researchers, was 306 days at FDA and 383 days at EMA. On average, reviews at FDA were 60 days shorter than reviews at EMA for therapeutics approved between 2011 and 2015.
However, the authors also noted that while review times were shorter at FDA for therapeutics intended to treat cancer and hematologic diseases, this was not the case for other therapeutic areas. They also found the review time was longer at FDA compared with EMA for orphan drugs.
The NEJM study authors said the statistics are comparable to, and greater than, a
The new presidential administration has become increasingly critical of FDA’s approval process. President Trump has referred to the process as “slow and burdensome” and the administration is putting
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