Top US FDA Global Regulator Joins Major Law Firm's Health-Care Division
Howard Sklamberg, the former US FDA deputy commissioner for global regulatory operations and policy who left the agency in April, will now join the health-care practice at the law firm Akin Gump.
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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.
The digital medtech sector is growing fast. As new companies enter the space, they are going to face oversight from a slew of government agencies and statutes. While FDA is an important focus for medtech, patient privacy and cybersecurity challenges for digital products raise other, significant compliance challenges. Medtech Insight discussed the range of hurdles the digital medtech industry faces with attorneys from Akin Gump.