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The FDA has handed Hospira its seventh warning letter in seven years and the second in the past six months, this time for poor sterile processing, inadequate batch failure investigations and data integrity weaknesses at its Liscate, Italy, manufacturing plant. Read More
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