Karl M. Nobert, Of Counsel

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Karl Nobert focuses his practice on the representation and counseling of clients in the food and drug industry including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine, medical devices, food and dietary supplements. Learn More

Practice Areas

Overview

Karl Nobert focuses his practice on the representation and counseling of clients in the food and drug industry including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine, medical devices, food and dietary supplements. Karl also assists clients with the preparation of FDA submissions including human and veterinary new drug and generic drug applications; 510(k) premarket notifications, premarket approval applications, recalls and market withdrawals, GRAS self-affirmations and notifications, and product listings and establishment registrations.

He represents clients before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA) and Federal Trade Commission (FTC). Karl also represents clients in state food and drug law matters on various regulatory matters including wholesaler/distributor licensing and registration.

Karl currently serves as Legal Advisor to the International Veterinary Regenerative Medicine Society (IVRMS) and is a member of the National Thoroughbred Racing Association’s (NTRA) Safety and Integrity Alliance Subcommittee on Aftercare.

He is the author of numerous articles and frequently presents on various FDA regulatory topics.

Credentials

Education

  • Villanova University, J.D., 2002
  • Villanova University, M.B.A., 2002
  • University of North Carolina at Chapel Hill, B.A., 1997

Admitted

  • Connecticut
  • New York
  • District of Columbia

Representative Experience

  • Counseling manufacturers regarding premarket pathways and life cycle management strategies for pharmaceuticals, medical devices and combination products.
  •  Counseling branded and generic pharmaceutical clients on issues related to IND, NDA, ANDA and NADA submissions to the FDA including 505(b)(1) and 505(b)(2) filings, grandfathered drugs and DESI drug products.
  •  Assisting several early-stage medical device companies in obtaining PMA approvals and 510(k) clearances.
  • Representing companies that manufacture feed, feed ingredients, drugs, biologics and medical devices for animals.
  • Assisting both pharmaceutical and medical device firms in conducting due diligence evaluations of potential corporate acquisition targets.
  • Advising start-up biotech companies on the FDA approval and commercialization of proposed regenerative medicine product therapies.
  • Advising companies responding to FDA inspection reports (483s) and warning letters relating to manufacturing, quality control, labeling and promotion.
  • Defending a major international biologics company against a competitor’s challenge to its grant of orphan drug designation and approval.
  • Assisting clients with various food related regulatory matters such as reviewing product labels, preparing GRAS self-affirmations and notifications; and advising on several food recalls and market withdrawals.

Publications