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The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
The FDA slapped warning letters on two more drug outsourcing facilities for sloppy sterile processing, bringing to seven the number of compounders cited for sterile manufacturing deviations in the past six months. Read More
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