Clinical Study Report Release Could Compromise Patient Privacy, Groups Say
US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.
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The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.
Like ANDA evaluations, US FDA plans to use the word assessment to describe them for NDAs and BLAs.
Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.