Frederick A. Stearns

Frederick A. Stearns: Attorney with Keller and Heckman LLP
  • Partner at Keller and Heckman LLP (65 Attorneys)
  • Suite 500 West, 1001 G Street, N.W., Washington, DC 20001
    View Frederick A. Stearns's office location
  • Peer Reviews
    4.4/5.0
    Client Reviews
    No Reviews
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Biography

Frederick Stearns' practice involves a wide range of issues affecting manufacturing of prescription and over-the-counter drugs, medical devices, dietary supplements, and cosmetics.

Mr. Stearns helps product manufacturers evaluate the need for marketing approval from FDA, to pursue appropriate clearance when necessary, and address regulatory compliance issues with marketed products (including OTC drug monographs, product labeling and promotion, and current good manufacturing practices). He also works with clients to respond to FDA enforcement activities, navigate the interrelationship of the patent laws and the FDA drug approval process, communicate with Agency officials, and develop innovative strategies to deal with evolving FDA regulatory requirements. In addition, Mr. Stearns has worked with numerous companies to conduct FDA due diligence reviews, both for internal control purposes and as part of product line or corporate acquisitions.

Mr. Stearns is a frequent speaker at conferences on the legal issues involving the regulation of drugs, medical devices, and dietary supplements.

News

•Aug 15, 2017 Rick Stearns Will Present FDA Food Inspection and Enforcement Authority
•Jul 28, 2017 Rick Stearns to Present Device Recalls and Withdrawals at the American Conference Institute (ACI): 5th Annual FDA Boot Camp - Devices Edition
•Mar 16, 2017 Rick Stearns Quoted in Law 360 Article Trump's Hiking of FDA User Fees Unlikely to Speed Approvals
•Sep 22, 2016 Rick Stearns to Present Understanding the Clinical Trial Process for Drugs and Biologics
•Sep 17, 2016 Rick Stearns Will Present An Overview of FDA's Abbreviated New Drug Application (ANDA) Requirements
•Jan 28, 2016 Partner Rick Stearns to Serve on Panel at the New York State Bar Association's Annual Meeting of the Food, Drug and Cosmetic Law Section
•Mar 04, 2015 Rick Stearns to Present at ACI's Legal, Regulatory & Compliance Forum on Cosmetics

Events

•Oct 25, 2017 Practical Food Law Seminar - Brussels, Belgium
•May 02, 2017 The Connected Product Intensive: A Framework for Regulatory Compliance and Risk Management Roundtable
•Mar 29, 2016 Webinar: Know Your Food Suppliers - New FSMA Responsibility, Liability, and Insurance
•May 06, 2014 TSCA & FDA Seminar - Indianapolis, IN

Articles

•Aug 29, 2016 Summaries on FDA's Final Rule on GRAS Notices and the Draft Guidance Document on New Dietary Ingredient Issues
•Jul 24, 2015 FDA Announces Supplemental Proposal to the Nutrition and Supplement Facts Labels
•Apr 25, 2014 Vermont Legislature Passes GMO Labeling Bill
•Feb 27, 2014 FDA Announces Major Revisions to the Nutrition and Supplement Facts Labels
•Aug 15, 2013 FDA Issues Revised Draft Guidance on Medical Foods
•Jun 26, 2012 Form 483s Can be Material Under Federal Securities Law
•Mar 05, 2012 FDA Publishes Three New Draft Guidance Documents on Biosimilar Product Development

Areas of Practice (3)

  • Advertising and Promotion
  • Biotechnology
  • Food & Drug

Education & Credentials

Contact Information:
202.434.4288  Phone
202.434.4646  Fax
www.khlaw.com
University Attended:
Cornell University, B.S., 1988
Law School Attended:
George Washington University Law School, J.D., with honors, 1993
Year of First admission:
1993
Admission:
1993, Virginia; 1995, District of Columbia
Memberships:

Memberships

•American Bar Association

ISLN:
900647169

Peer Reviews

  • 4.4/5.0
  • A Martindale-Hubbell Peer Rating reflects a combination of achieving a Very High General Ethical Standards rating and a Legal Ability numerical rating.

*Peer Reviews provided before April 15, 2008 are not displayed.

Client Reviews

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