|University ||Cornell University, B.S., 1988|
|Law School||George Washington University Law School, J.D., with honors, 1993|
|Admitted||1993, Virginia; 1995, District of Columbia|
Frederick Stearns joined Keller and Heckman in 1993. His 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.
Documents by this lawyer on Martindale.com
Notable Provisions of H.B. 112
Melvin S. Drozen,Leslie T. Krasny,Eric S.C. Lindstrom,Richard F. Mann,Frederick A. Stearns, April 30, 2014
Section 3403 sets forth the GMO labeling requirements in Vermont. Foods that are produced entirely or partially with genetic engineering must be labeled as follows:
FDA Announces Major Revisions to the Nutrition and Supplement Facts Labels
Melvin S. Drozen,Leslie T. Krasny,Eric S.C. Lindstrom,Richard F. Mann,Frederick A. Stearns, March 5, 2014
Today, the Food and Drug Administration (FDA) announced the availability of three proposed rules that would revise the Nutrition Facts label requirements. These proposals will be published in the Federal Register on Monday, March 3.
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