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Drug wholesaler Amerisourcebergen agreed in federal court to pay $260 million and plead guilty to violating federal drug law via a criminal scheme to sell cancer drugs illegally repackaged in pre-filled syringes. Read More
The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and surveillance data. Read More
The FDA published a new manual of policies and procedures for reviewing staff, detailing how the agency will communicate ANDA deficiencies with applicants — meeting one of its first commitments for the next generation of GDUFA. Read More
The agency must adjust the incremental cost from fiscal 2016 by the average amount costs rose in the three years before the current fiscal year. Read More
The FDA cited a Dallas home infusion therapy pharmacy for failure to maintain sterile conditions for drugmaking after inspectors found dead insects in a cleanroom and in refrigerators used to store ingredients and finished products. Read More
A New York City pharmacy that produces drugs as part of the multibillion-dollar Magellan Health healthcare management corporation was cited in an FDA warning letter for failure to maintain sterile processing procedures. Read More
Drugmakers wishing to use emerging manufacturing technology should ask to participate in an FDA program designed to help them through the approval process for new medicines, the agency said in finalizing draft guidance issued in 2015. Read More
An FDA advisory committee voted 10 to 1 Wednesday that a muscular dystrophy drug candidate does not have enough supporting data to be considered effective. Read More