Baxter Extraneal Hypoglycemia Testing Program Is Condition Of FDA Approval
Baxter will initiate an Extraneal physician and patient educational campaign to help avoid falsely elevated glucose tests following FDA approval of the peritoneal dialysis solution
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Baxter's dialysis agent Extraneal should be studied in Phase IV trials measuring hypertension and mortality, FDA's Cardiovascular & Renal Drugs Advisory Committee recommended Aug. 9.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials