FDA Approvals - FDA Issues Alert On Bed Wetting Drug (Medical News Today)
FDA Issues Alert On Bed Wetting Drug (Medical News Today)
The US Food and Drug Administration (FDA) has asked the manufacturers to update drug labels and prescription information on desmopressin, available in tablet and nasal spray form and used to treat bed wetting, to include new information about severe hyponatremia, a condition caused by insufficient sodium in the blood which leads to seizures and sometimes death. [click link for full article]
Bradmer Medical Isotope Supply For Phase III Trial Secure (CNW Group via Yahoo! Finance)
Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, today announced that the start of Company's planned Phase III trial of Neuradiab, a murine monoclonal antibody radiolabeled with Iodine-131 , is unaffected by the recent shortage of medical isotopes from a nuclear facility in Chalk River, Ontario.
Pharmaceutical, Healthcare & Life Sciences (Mondaq)
Ted Acosta and Eileen Erdos of Ernst & Young discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.