Bial Drug Tragedy: French Senate To Look Afresh At Clinical Trial Rules
This article was originally published in SRA
A French Senate committee has intervened in the debate over the Phase I study of a new drug that caused the death of one volunteer and led to the hospitalization of several others, saying that it plans to meet with the government inspectors who visited the site in Rennes to discuss their findings, with a view to looking afresh at the legislation governing clinical trials1.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.