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Ex-US FDA Official Sklamberg On Park Doctrine Limits, Data Integrity

 
• By Anju Ghangurde

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.

Compliance
SKLAMBERG EXPECTS COURTS TO WEIGH IN ON THE PARK DOCTRINE ISSUE

Howard Sklamberg, the former US FDA deputy commissioner for global regulatory operations and policy, was in Mumbai to address the India Pharmaceutical Forum 2018, an annual event where regulators, industry and other experts essentially discuss all things quality and compliance.Also see "Data Integrity Failures Undermine Trust That Can’t Easily Be Won Back, EMA Official Says" - Pink Sheet, 28 February, 2017.

In an interview with the Pink Sheet at the JW Marriott perched along the picturesque Juhu beach, Sklamberg, who is now with law firm Akin Gump as a partner in...

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