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A House subcommittee chairman wants the FDA to explain its practices relating to publication and distribution of untitled letters, after hearing complaints from companies that the agency’s policies are inconsistent and, in some cases, unfair. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More
ISPE’s quality metrics team has narrowed from 16 to five the number of metrics it will ask drugmakers to collect data on during phase two of a pilot program aimed at helping the FDA boost quality compliance. Read More
FDA approval of Pfizer subsidiary Wyeth’s Rapamune for lymphangioleiomyomatosis may be the light at the end of the tunnel for sufferers of the extremely rare lung disease. Read More
While nearly three-quarters of generic drugs saw prices fall in 2013, the 27 percent that saw price increases led to the smallest average annual decline in seven years, a new report finds. Read More
The FDA on Wednesday approved Patheon Pharmaceuticals’ Viberzi and Salix Pharmaceuticals’ Xifaxan for the treatment of irritable bowel syndrome with diarrhea in adult patients. Read More