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Some patients in Novartis' pediatric leukemia pivotal trial for tisagenlecleucel (CTL019) received out-of-spec product following the sponsor's consultation with US FDA, and the same thing might occur in the commercial setting.
Latest From Manufacturing
President announces Merck, Pfizer and Corning collaboration on new glass packaging for injectable drugs as part of "Made In America Week;" says FDA is streamlining regulations.
FDA has announced its intent to establish a supply chain pilot program with the input of the pharmaceutical industry and is holding three upcoming meetings on supply chain security.
The head of US FDA's drug quality office, Michael Kopcha, rebukes industry pushback that got White House's ear and demands more constructive feedback on quality metrics. Industry workshop participants come up with creative ideas, but FDA finds them problematic. Asked whether industry should dive in or wait and see on voluntary phase of metrics initiative that begins in January, another FDA official says, "That's a tough one."
India, one of the largest generic drug producers globally, is considering banning animal-origin gelatin capsules to respect the “religious sentiments” of the large number of Indians who are vegetarian, but groups are raising objections.
EU pharmaceutical and industry officials note some common trends and similarities in post-approval changes for biosimilars and reference products. One vexing problem in instituting post-approval changes is whether to use the reference drug or the approved biosimilar and regulatory guidance in this area is lacking.
Measure to provide $5.2b to FDA in FY 2018; amendment on office-use compounding withdrawn after House Appropriations Committee agrees to work to get FDA to allow practice.
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