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The FDA warned a Chinese maker of active pharmaceutical ingredients over data integrity lapses and other serious deviations from current good manufacturing practice. Read More
The FDA increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. Read More
The FDA increased its generic preapproval inspections by 60 percent between FY 2011 and 2013, but didn’t conduct all those requested by agency reviewers. Read More
The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More
Health Canada has launched an online public database of information relating to drug company inspections, including which firms have a good history of meeting safety and quality standards and which do not. 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’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
The FDA increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. 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 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