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Steven Niedelman
News 6 results
In the News · Source: Medtech Insight
May 25, 2022
Steve Niedelman discusses the stakeholder comments on the U.S. FDA’s proposed Quality Management System Regulation
Cases & Deals
December 7, 2021
King & Spalding Advises Oaktree Acquisition Corp. II in its Merger with Alvotech
In the News · Source: Medtech Insight
April 23, 2021
Steve Niedelman explains the steps that companies should follow to prepare for a regulatory meeting with the FDA
In the News · Source: BioProcess Online
January 19, 2021
BioProcess Online profiles Steven Niedelman and Christina Markus
Events 10 results
Webinar
November 9, 2021
King & Spalding Pharmaceutical University 2021
Webinar
September 9, 2021
14th Annual King & Spalding Medical Device Summit
Webinar
February 23, 2021
FDA Inspections in 2021 for Drug and Device Manufacturers
Speaking Engagement
December 23, 2020
Eric Henry, Steve Niedelman to Speak on Global Medical Device Podcast
Insights 13 results
Client Alert
December 19, 2022
FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance
Client Alert
Client Alert
March 1, 2022
The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards
Client Alert
December 30, 2021
FDA Issues Draft Guidances on Transitioning Devices from EUAs and Agency Enforcement Policies