Sentences with phrase «approved by regulatory authorities»

The vaccine would require a commercial partner and must be approved by regulatory authorities.

Members of the Genome Informatics Working Group have recognized the need to provide a comprehensive resource for pharmacogenomic biomarkers information for those drugs that are approved by regulatory authorities.

He concluded: «Once it is approved by the regulatory authorities, I'll consider niraparib for all my patients with recurrent ovarian cancer who respond to platinum regardless of BRCA status.»

Not exact matches

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

The authors of the commentary emphasize that cell therapies must be approved by international and national regulatory agencies and remain under the strict vigilance of health authorities.

Dihydroartemisinin - piperaquine also became one of the few antimalarials to be formally registered by a stringent regulatory authority when the European Medicines Agency approved it for use in 2013.

Tissue Genesis» Icellator ® is approved for use by medical regulatory authorities in South Korea, the Ukraine and the Bahamas, with ongoing FDA - cleared trials in the USA for multiple indications of chronic disease.

Trifexis (spinosad + milbemycin oxime) has been rigorously tested and approved as safe by the FDA and other regulatory authorities around the world.

So not only do you have your veterinarian looking out for your dog's health, you also have a product that was approved as safe by the FDA and other regulatory authorities around the world.

For purposes of this subsection, «State - approved production incentive program» means a requirement imposed pursuant to State law, or by a State regulatory authority acting within its authority under State law, that an electric utility purchase renewable energy (as defined in section 609 of this Act) at a specified rate.».

-- Notwithstanding any other provision of this Act or the Federal Power Act, a State legislature or regulatory authority may set the rates for a sale of electric energy by a facility generating electric energy from renewable energy sources pursuant to a State - approved production incentive program under which the facility voluntarily sells electric energy.

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