Volume 95 Issue 2 | p. 11 | News of The Week
Issue Date: January 9, 2017

Drug manufacturing woes grow

FDA inspections raise issues that delay approvals
Department: Business
Keywords: pharmaceuticals, manufacturing, FDA, approval

Several companies are trying to overcome manufacturing roadblocks that stopped their new drugs from being approved by FDA in 2016. In responses to their applications, FDA cited problems found during preapproval plant inspections. Most problems were in Western facilities and centered on formulation, rather than active ingredient production.

Only two companies—AstraZeneca and Opko Health—responded to the problems in time to refile in 2016. And Opko got an approval after its manufacturing partner, Catalent, fixed problems . . .

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