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Complex Generics Guidance: US FDA Aims To Alert Firms, As GAO Requested

 
• By Joanne S. Eglovitch

The US FDA says it's working to provide the type of notice generic drug firms told the General Accountability Office they want to receive whenever the agency plans to issue or revise product-specific guidance on complex generics. Surprise issuance causes setbacks for generic drug sponsors who must scramble to revise their applications accordingly, if they can.

Woman uses an inhaler during an asthma attack, close-up

US FDA Commissioner Scott Gottlieb said Jan. 16 the agency is working to accommodate concerns generic drug firms have raised that they are often blindsided by new or revised product-specific guidance documents from the agency that can delay or even derail applications for approval of non-biological complex generic drugs.

The concerns surfaced in a Jan. 16 report from a congressional oversight agency, the General Accountability Office. The GAO report, “FDA Should Make Public Its Plans To Issue...

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