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This profile was last updated on 11/6/14  and contains information from public web pages and contributions from the ZoomInfo community.

Mr. John R. Manthei

Wrong John R. Manthei?
 
Background

Employment History

Board Memberships and Affiliations

Education

  • JD
    University of Wisconsin Law School
  • BA
    Miami University
  • JD
    University of Wisconsin
  • law degree
    University of Wisconsin Law School
78 Total References
Web References
A discussion draft of the Cures ...
www.bioworld.com, 6 Nov 2014 [cached]
A discussion draft of the Cures reforms, which is likely to change the drug and device development process, is expected to be rolled out in January, leading to the passage of comprehensive legislation later in the year, said John Manthei, partner and global co-chair of Latham & Watkins' health care and life sciences practice.
"This will be an ambitious undertaking," he said of the Cures initiative. "I think the energy from both the Republicans and Democrats is there. The initiative has enjoyed strong bipartisan support in the House Energy and Commerce (E&C) Committee, as well as in its Health Subcommittee.
As a result of that support, Manthei predicted 2015 will see the broadest scope of FDA reforms ever for a year in which Congress isn't re-authorizing the five-year drug and device user fee package.
Along with those reforms, Manthei expects the Republican-controlled Congress to exercise more oversight of the FDA, seeking greater transparency, predictability and accountability in the agency's dealings with industry and in its handling of resources.
...
With the Republicans at the helm, Manthei expects Sen.
...
Henry Waxman (D-Calif.). Pallone, the current ranking member of the Health Subcommittee, is in line for the leadership seat in terms of seniority, but House Minority Leader Nancy Pelosi (D-Calif.) is expected to campaign for Eshoo, Manthei said.
...
Adding to their loss will be the departure of their experienced staff, Manthei said.
Advisory Committee | Neediest Kids
neediestkids.org, 25 July 2014 [cached]
John Manthei, Esq., Latham & Watkins
Latham & Watkins LLP - About Us - News - Medicis Pharmaceutical Advised in its $2.6 Billion Acquisition by Valeant
www.latham.com, 1 June 2014 [cached]
Advice was also provided on antitrust matters by partner Michael Egge with associate Jason Cruise in Washington D.C.: on benefits and compensation matters by partner Jim Barrall in Los Angeles with associate Carol Samaan in Orange County; on litigation matters by partners David Schindler in Los Angeles and Michele Johnson in Orange County; on regulatory matters by partner John Manthei with associate Elizabeth Richards in Washington D.C.; on intellectual property matters by partner Judith Hasko in Silicon Valley; on environmental matters by partner Christopher Norton in Orange County; and on tax matters by partner Nicholas DeNovio in Washington D.C.
...
John R. Manthei
BayBio  | BayBio
www.baybio.org, 19 June 2011 [cached]
John R. Manthei Partner, Latham & Watkins
John R. Manthei is a partner in the Washington, D.C. office of Latham & Watkins and serves as Global Co-Chair and Washington, D.C. Department Chair of the Healthcare and Life Sciences Practice. His practice focuses on regulatory matters involving the Food and Drug Administration (FDA) for the medical device, pharmaceutical, biotechnology, food and dietary supplement industries. Mr. Manthei's practice includes assisting clients with all aspects of the FDA-regulated product life cycle, including, among others: pre-market development; FDA product submissions; development of market exclusivity strategies; drafting and negotiation of both US and international clinical trial agreements; FDA and Federal Trade Commission (FTC) regulation of marketing and promotion of products; Quality System Regulation and Good Manufacturing Practice requirements (including assisting in third-party audits and drafting SOPs); FDA inspections; recalls; FDA and DEA export and import requirements; and civil and criminal compliance and enforcement. Prior to joining Latham, Mr. Manthei served as Majority Counsel for the US House of Representatives' Committee on Energy and Commerce (1998-2000). In this capacity, he counseled the Full Commerce Committee Chairman; the Health and Environment and Oversight and Investigations Subcommittee Chairmen; as well as the House Leadership on matters relating to the FDA and legislation concerning the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, and the Controlled Substances Act. Since 2000, Mr. Manthei has represented the pharmaceutical, biotechnology and medical device industries as counsel in nearly every major FDA legislative initiative. He has also testified before Congress on several occasions involving FDA and DEA regulatory and enforcement matters. Mr. Manthei serves as outside FDA counsel to the Medical Device Manufacturers Association (MDMA), is a member of the Food & Drug Law Institute's Advisory Committee for Drugs and Biologics. Mr. Manthei has authored numerous articles and has been a featured speaker and lecturer on FDA regulatory and enforcement matters at events sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA), the Biotechnology Industry Organization (BIO), AdvaMed, MDMA, BioCom, BayBio, the Food and Drug Law Institute (FDLI), the American Health Lawyers Association (AHLA), GMA, Harvard University, Stanford University and MIT, among others.
About FDLI - Committees
www.fdli.org, 4 Dec 2009 [cached]
John Manthei, Latham & Watkins
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