FDA ACRA Mel Plaisier on ORA Program Alignment

Associate Commissioner for Regulatory Affairs Melinda Plaisier discusses Program Alignment

FDA Commissioner Dr. Robert Califf hosted a series of video interviews with people at the FDA called “Conversations with the Commissioner.” In this interview, Melinda Plaisier, Associate Commissioner for Regulatory Affairs, discusses Program Alignment. I welcome your input on this subject as NTEU in negotiations over this drastic change in working conditions.

2 thoughts on “FDA ACRA Mel Plaisier on ORA Program Alignment”

  1. FDA’s program alignment is a rare example of a government bureaucracy conducting a major internal reorganization in the absence of an immediate external crisis. Not coincidentally, it will also offer Congress the opportunity to eventually create a food safety agency, and a medical products agency, with much less program disruption.

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  2. Being a die hard, old school exFDAer, I must comment I am not in favor or this drastic change. Having been through the similar failed attempt by a former ACRA, trying to fix something which “ain’t” broke seems foolish and a huge waist of the taxpayers money. The whole thing seems to stem from CDERs attempt to gain omnipotency. CDER is already undermining field inspections according to my “anonomous” sources.

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