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Morgan Lewis
Phoebe Mounts
Phoebe Mounts
Morgan Lewis
FDA Delays EMDR System Adverse Event Codes Update
05 Apr 2018 | United States
FDA Issues Final Rule On Data Acceptance From Clinical Investigations For Medical Devices
28 Feb 2018 | United States
FDA Doubles Down On Efforts To Develop Guidance For Clinical Trial Stakeholders
06 Feb 2018 | United States
OCR Announces First HIPAA Settlement With Wireless Health Services Provider
10 May 2017 | United States
FDA Issues Draft Guidance As Part Of Precision Medicine Initiative
01 Aug 2016 | United States
Medical Device Update: Distinguishing Medical Device Recalls From Medical Device Enhancements
05 Nov 2014 | United States
FDA Releases Details Of New Framework For Laboratory Developed Tests Regulation
06 Aug 2014 | United States
Medical Device Update: FDA Medical Device Guidances Issued In 2014’s Second Quarter
28 Jul 2014 | United States
FDA Issues Proposed Regulations On Medical Device Classification And Reclassification To Streamline The Process
03 Apr 2014 | United States
Medical Device Update: FDA Releases Final Pre-Submission Guidance
12 Mar 2014 | United States
March 2014 Medical Device Update
11 Mar 2014 | United States
FDA Issues Three Draft Guidances For Biosimilars
21 Feb 2012 | United States
FDA Issues Draft Guidance On 510(k) Device Modifications: New Emphasis On Potential Impact Of Modifications
08 Sep 2011 | United States
FDA Requests Comments On The Development Of A User Fee Program For Biosimilar And Interchangeable Biological Products
26 May 2011 | United States
FDA Proposes To Expand The Scope Of Clinical Investigator Disqualifications
19 Apr 2011 | United States
FDA Preserves 510(k) Pathway; Announces Initial Modifications in Reform Program
30 Jan 2011 | United States
FDA Proposed Rule Requires Reporting Suspected Falsification of Data in Studies with Human or Animal Subjects
19 Apr 2010 | United States
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United States

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