Ex-US FDA Official Sklamberg On Park Doctrine Limits, Data Integrity
Courts may increasingly find limits on how far Park Doctrine tool can be ‘pushed,’ Sklamberg says in wide-ranging interview with the Pink Sheet. Former US FDA deputy commissioner for global regulatory operations and policy, now with law firm Akin Gump, also shares his views on the US-EU MRA to recognize each other’s inspections and data integrity.
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Moving up the manufacturing compliance curve is still a work in progress for several Indian firms, but there appear to be some early signs that US FDA inspection outcomes, in general, may have improved.
FDA’s expectation is that the most responsible individual at manufacturing sites be involved in inspections. The agency is increasingly talking about its “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems.