Post-approval nightmares shared in biopharmaceutical CMC strategy session. One firm's 'impossible' task: making a drug 55 different ways for 105 countries.
A few of the people who must manage the extraordinarily complex process of winning regulatory approval to improve pharmaceutical manufacturing processes for global markets shared their experiences at a recent forum on post-approval manufacturing changes.
Speaking at a July 21-22 California Separation Science Society (CASSS) CMC Strategy Forum in Gaithersburg, Md., the industry officials explained...
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An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
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