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HHS Wednesday proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
Allergan said Wednesday that results from two Phase 3 studies evaluating Avycaz in hospitalized adults with complicated urinary tract infections, including pyelonephritis, affirm the drug’s safety and efficacy. Read More
By a two to one vote, a Federal Circuit Court of Appeals panel cleared the way for Sandoz’s launch of Zarxio, the first FDA-approved biosimilar, as early as today. Read More
Requiring drug compounders to provide information on all products taken by a patient that may be “suspect” in an adverse reaction would be unduly burdensome, necessitating full access to a patient’s medical records, the International Academy of Compounding Pharmacists says. Read More
A flu vaccine manufacturing site that was recently transferred from Novartis to CSL Limited received an FDA Form 483 for problems with cleaning equipment, stability studies, batch certification and other issues. Read More