All diabetes medications henceforth were required to conduct large -
scale safety trials to safeguard the public interest.
Not exact matches
If large -
scale trials can replicate
safety and efficacy results, the drug could be approved for legal use by 2021.
Wolfe acknowledges, however, that we won't know what the long - term
safety issues are until a large -
scale human
trial is conducted, which researchers hope to begin in the next three years.
Promising outcomes of preliminary studies in patients in Southeast Asia and parts of Western and Central Africa led the World Health Organization to make the recommendation, but
safety and efficacy have not yet been proven in large -
scale clinical
trials.
At the meeting, GlaxoSmithKline (GSK) of Rixensart, Belgium, which has the vaccine furthest in development, spelled out how it might
scale up production in parallel with the
safety and efficacy
trials now under way so that the product could be ready for wider distribution by April if warranted.
«To preserve patient access to this treatment option, and given the
scale that we've reached, demonstrating the
safety and efficacy of fecal transplantation through adequate and well - controlled clinical
trials is the right thing to do,» explained Carolyn Edelstein, OpenBiome's director of Outreach and Public Affairs, in an op - ed published earlier today with the Fecal Transplant Foundation.