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The FDA is edging toward requiring pharmaceutical excipient makers to adopt quality systems and has collaborated with standards development groups in developing an excipients GMP standard. Read More
The FDA wants to kill a lawsuit that would force it to order Johnson & Johnson to release confidential documents it used to demonstrate the safety of its antipsychotic Risperdal and reconsider a citizen petition that sought stronger safety warnings for the drug. Read More
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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