FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate dehydrogenase complex deficiency.
FDA releases the 17-page form FDA-483 following a May inspection at India’s Strides Pharma Science drug manufacturing facility in Bangalore.
FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate dehydrogenase complex deficiency.
FDA releases the 17-page form FDA-483 following a May inspection at India’s Strides Pharma Science drug manufacturing facility in Bangalore.
In its report on FY 2024 approvals of medical devices for pediatric uses, FDA says that 19 of the 56 device approvals that year were indicated for use in a pediatric population or sub-population.
FDA releases the form FDA-483 with three observations from an inspection at the Novel Laboratories (Lupin) drug manufacturing facility in Somerset, NJ.
