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James S. Cohen, Partner
- 202-756-8276
- jcohen@mwe.com
- www.mwe.com
James (Jim) S. Cohen is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office. He is head of the Firm's Food and Drug Administration (FDA) practice. Jim focuses his practice on the development, clinical investigation, approval, and marketing of drugs, medical devices, biologics, combination products, and other FDA regulated products. He has been recognized by Legal 500 as one of the leading lawyers in his field.
- McDermott Will & Emery
Articles in the National Law Review database by James S. Cohen:
- FDA Finalizes Rule Expanding Scope of Clinical Investigator Disqualification (Posted On Tuesday, May 22, 2012)
- FDA Finalizes Benefit-Risk Determination Methodology for Certain Medical Devices (Posted On Sunday, April 22, 2012)
- FDA Issues Draft Guidance Implementing Direct-to-Consumer Television Ad Pre-Dissemination Review Program (Posted On Monday, April 9, 2012)
- IFPMA Releases Revised Code for Interactions with Health Care Professionals and Other Stakeholders (Posted On Tuesday, March 20, 2012)
- FDA Schedules Public Hearing to Evaluate Potential New Drug Approval Paradigm (Posted On Wednesday, March 7, 2012)
- FDA Publishes Draft Biosimilars Guidance (Posted On Friday, February 17, 2012)
- FDA Clarifies Use of Product Names in Advertising and Promotional Labeling (Posted On Saturday, February 4, 2012)
- FDA Issues Draft Guidance, Requests Public Comments on Communication of Off-Label Information (Posted On Thursday, January 5, 2012)
- HHS Extends Comment Period for Advanced Notice of Proposed Rule Making Concerning the Common Rule (Posted On Sunday, September 11, 2011)
- The IOM Report on Reform of the 510(k) Device Clearance Process and Beyond (Posted On Friday, August 19, 2011)
- HHS Proposes Overhaul of Human Subject Protections for Domestic Clinical Trials (Posted On Thursday, July 28, 2011)
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