Because the data underlying accelerated approval is often less compelling, Genentech had to repeat the trial that got Avastin approved in the first place, showing that its benefits outweighed its risks.
The pivotal trials underlying the approvals of ophthalmic drugs in our study cohort enrolled a median of 809 patients.
Despite their importance, the characteristics of the key trials underlying the approvals of ophthalmic therapeutics have not been defined.
So I'm writing a series of posts about these trials, which underlie regulatory approval of new medicines.
But meanwhile, he says, "transparency is needed" on the studies underlying NK603's approval, "so they can be scrutinized in the same persnickety way as … my study".
The agency is no stranger to Séralini's work: In 2007, it investigated a paper of his that challenged the statistical analyses underlying EFSA's approval of Monsanto's maize variety MON 863.
15 16 We first sought to assess the characteristics of the clinical evidence underlying supplemental indication approvals in the same way that other investigators have studied such data in original drug approvals: using publicly available FDA medical reviews, which are documents that explore in detail the efficacy and safety of the novel agent demonstrated in clinical trials.
Again, while the outcome often manifests in delays in regulatory approval, the underlying causes often vary across nations.
Has there been a real shift in underlying values, or are the current approval ratings a kind of "sugar high" that will quickly dissipate?
The following information was collected including age, sex, underlying diseases, et al. This investigation had the approval of the Ethics Committee of Beijing Chaoyang Hospital and informed consent was obtained from all study subjects or their next of kin.
The main underlying factor for 2010 and this election, President Obama's approval rating, is at the same 47% it's been since late February.
