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Drugmakers can now make minor changes to drug safety assurance plans without waiting for FDA approval, reducing some of the burden of managing risk evaluation and mitigation strategies. Read More
The European Medicines Agency has approved a new use of Amgen’s Vectibix as first-line treatment in combination with Folfiri chemotherapy for metastatic colorectal cancer, the drugmaker said Monday.
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The FDA issued priority review vouchers to sponsors of two rare pediatric disease therapies, United Therapeutics’ cancer drug Unituxin and Asklepion Pharmaceuticals’ Cholbam for a severe metabolic disorder. Read More
Drugmakers exporting drugs from India must now include barcodes on all tertiary and secondary packaging. The policy, intended to assure the safety and effectiveness of therapies reaching patients in the U.S. and elsewhere, affects drugs made on or after April 1, 2015. Read More
In the next few years, drugmakers will have to collect quality metrics data for FDA investigators to use in determining a facility’s quality status. Metrics being bandied about include batch failure rates, CAPA rates, complaints and right-first-time rates. Read More
Drugmakers seeking approval of genetically engineered products must begin submitting an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More