James Allred

James Allred Email and Phone Number

Associate Chief Counsel, FDA @ FDA
silver spring, maryland, united states
James Allred's Location
Washington DC-Baltimore Area, United States
James Allred's Contact Details
About James Allred

James Allred is a Associate Chief Counsel, FDA at FDA. He possess expertise in fda law, life sciences law, pharmacy compounding, biotechnology industry, pharmaceutical industry and 28 more skills.

James Allred's Current Company Details
FDA

Fda

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Associate Chief Counsel, FDA
silver spring, maryland, united states
Website:
fda.gov
Employees:
14770
James Allred Work Experience Details
  • Fda
    Associate Chief Counsel
    Fda Jan 2021 - Present
    Washington Dc-Baltimore Area
    Civil litigator, Office of the Chief Counsel, US Food and Drug AdministrationI defend FDA in civil litigation challenging the agency's scientific and regulatory determinations and also handle civil enforcement matters in coordination with Department of Justice attorneys. The role includes advising agency policymakers on litigation risk in policy development. I also review other attorneys' work product in their work defending FDA.
  • Drug Enforcement Administration
    Attorney, Diversion And Regulatory Policy Section, Office Of The Chief Counsel
    Drug Enforcement Administration Mar 2018 - Jan 2021
    Arlington, Virginia
    I advised the agency on the full range of regulatory and policy matters under the Controlled Substances Act (CSA), including regulatory control of prescription drug manufacturers & prescribers, drug scheduling, and quotas. I also drafted and revised legislation, scheduling determinations, and new regulations. I represented DEA in interagency proceedings and policy discussions. DEA turned to me as a point person on interpretation of the hemp provisions of the Agriculture Improvement Act (2018 farm bill). I advised DEA attorneys and prosecutors on pharmaceutical diversion enforcement matters.
  • Hogan Lovells
    Senior Associate
    Hogan Lovells Oct 2013 - Feb 2018
    Washington D.C. Metro Area
    FDA Pharmaceuticals and Biotechnology groupSenior Associate: 2018Associate: 2013 - 2014 and 2015 - 2017Summer Associate: 2012I counseled clients on compliance with the Food, Drug, & Cosmetic Act (FDCA) and represented client interests before FDA, DEA, & state governments in citizen petitions, letters, & presentations to regulatory bodies. I offered advice across FDCA topics with a particular focus in Hatch-Waxman exclusivities and patent-term extension, pharmacy compounding, supply chain track and trace, user fees, and design and implementation of REMS. I also guided clients through government investigations and groundbreaking litigation challenging FDA and state regulatory decisions.
  • U.S. Court Of Appeals For The Tenth Circuit
    Law Clerk To The Hon. Jerome Holmes
    U.S. Court Of Appeals For The Tenth Circuit Jul 2014 - Aug 2015
    Oklahoma City, Oklahoma Area
    I researched cases before the Tenth Circuit and wrote bench memos to prepare the Judge for oral argument. I also drafted judicial opinions and advised the Judge on pending motions.
  • Winchester College
    Wykeham Fellowship: Don (Teacher) Of Chemistry
    Winchester College Aug 2007 - Jul 2008
    Winchester, Hampshire, United Kingdom
    I taught three classes of Year 9 (age 13-14) and two classes of Year 10 (age 14-15) Chemistry according to the IGCSE curriculum. I also taught one class of Upper-6th Form (age 17-18), post-A Level Advanced Chemistry. I was responsible for pastoral care duties including weekly tutoring and coaching responsibilities. I developed a full curriculum in Advanced Chemistry.

James Allred Skills

Fda Law Life Sciences Law Pharmacy Compounding Biotechnology Industry Pharmaceutical Industry Pharmaceutical Law Fda Compliance Biologics Outsourcing Facilities Pharmaceutical Compounding Pharmaceutical Advertising And Promotion Fda Regulation Compounding Internal Investigations Government Investigations Litigation Legal Research Warning Letter Response Due Diligence Regulatory Due Diligence Government Regulations Regulatory Law Cosmetics Otc Drugs Clinical Trials Biosimilars Orphan Drugs Hatch Waxman Rems Controlled Substances Dea U.s. Food And Drug Administration Controlled Substance Scheduling

James Allred Education Details

Frequently Asked Questions about James Allred

What company does James Allred work for?

James Allred works for Fda

What is James Allred's role at the current company?

James Allred's current role is Associate Chief Counsel, FDA.

What is James Allred's email address?

James Allred's email address is js****@****ail.com

What schools did James Allred attend?

James Allred attended University Of Virginia School Of Law, Emory University, University Of North Carolina At Chapel Hill, Princeton Theological Seminary, Chapel Hill High School.

What skills is James Allred known for?

James Allred has skills like Fda Law, Life Sciences Law, Pharmacy Compounding, Biotechnology Industry, Pharmaceutical Industry, Pharmaceutical Law, Fda Compliance, Biologics, Outsourcing Facilities, Pharmaceutical Compounding, Pharmaceutical Advertising And Promotion, Fda Regulation.

Who are James Allred's colleagues?

James Allred's colleagues are Crystal Jones, David Acevedo, Ephraim Leibtag, Matt Lash, Caroline Hobson, Marvin Jones, Megan Gatski.

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