Jur T. Strobos, Attorney

Jur Strobos Lawyer

Jur T. Strobos update listing

Food Products, Food & Drug Administration, Life & Health, Medical Products & Devices, General Practice, Pharmaceutical Product


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Dr. Strobos is Of Counsel at Olsson Frank Weeda Terman Bode Matz P.C.  Dr. Strobos has extensive scientific and legal training as well as substantial management experience in the pharmaceutical industry.  He served as the Director of the Policy Research Staff in the Office of the Commissioner at the U.S. Food and Drug Administration.  He worked closely with then-FDA Commissioner Kessler on regulatory policy, drug promotion, standards for review of clinical studies, drug and medical device review and approval, biological product and human tissue review and approval, international harmonization of review standards, electronic submissions, mammography quality, federal healthcare financing of investigational devices and informed consent.  After practicing regulatory law in Washington, DC, Dr. Strobos held executive positions at three pharmaceutical firms as their VP of clinical research and regulatory affairs (two start-ups and one NYSE-listed company).  His responsibilities included regulatory affairs, and nonclinical and clinical development of drugs, medical devices, and biological products.  Dr. Strobos has been intimately engaged in the creation, filing, and regulatory issues involved in INDs, NDAs, PMAs, and BLAs, including the manufacturing, nonclinical, clinical and regulatory issues.  Dr. Strobos has performed a pivotal role in the regulatory and/or clinical strategy of several marketed products, including Ferrlecit, the DePuy ACS Knee, Perlane, Solodyn, Restylane, Hectorol, ResQPOD, as well as many products currently under IND.

His current practice has recently included advising with regard to Stem Cell Therapy, Manufacturing Compliance, Advisory Committee Preparation, Transgenic Animals, Bioterrorism, Orphan Drugs, Humanitarian Devices, Import Licenses/Alerts, Debarment Proceedings, Pharmacovigilance, International Drug Regulations (Canadian and EMEA Drug Regulations, European Notified Body Compliance), eCTD, OTC/Generic Drugs, Human Tissues, Pharmaceutical Licensing and Due Diligence, Marketing and Promotion, and FDA-Related Litigation Support.  His practice spans the Centers for Drug Evaluation and Research, Biologics Evaluation and Research, and Devices and Radiological Health, and has included impact on regulatory policy in the review of applications in orthopedics, oncology, nephrology, hematology, cell therapy, AIDS, endocrine and metabolism, counterterrorism, and dermatology.

Areas of Practice:

Food and Drug Law

Medical Product Development

Federal Service:

US Court of Appeals, Federal Circuit, Clerkship

US Food and Drug Administration, Commissioner's Office

Bar Admissions:

District of Columbia

California

U.S. Patent Bar

Education:

The University of Pennsylvania Law School, Juris Doctor

The University of Chicago, Doctor of Medicine

Johns Hopkins University, Bachelor of Arts (Cum Laude)

Honors:

Fellow, American College of Emergency Medicine

Special Recognition Award (U.S. Public Health Service)

Award of Merit (U.S. Food and Drug Administration)

Commissioner's Special Citation (U.S Food and Drug Administration)

Rossman Prize (Commissioner of Patents and Trademarks)

Board Member, Forman School for the Educationally Disabled (2002-2006)

Selected Publications:

  •  Post-Marketing Black Box Warnings: The Anti-Calcineurin Story

  • Immunogenicity Studies of Cosmetically-Administered Non-Animal Stabilized Hyaluronic Acid

  • Single-dose pharmacokinetics of Ferrlecit  in iron-deficient subjects

  • Introduction to Food and Drug Law: OTC Drugs

  • Regulation of Pharmacoeconomic Information in the Managed Care Marketplace

  • Effect of Current FDA Regulation on Innovation in Patient Care

  • U.S. Regulation of Tissues. European Association of Tissue Banks

  • Regulating Marketing Innovation: Marketing and Promotion

  • Food and Drug Administration Oversight of Clinical Software

  • Food and Drug Administration Regulations Exception from Informed Consent Requirements

  • Building Bridges Between Academia and Industry

  • Ferrlecit Adverse Reactions in Iron Dextran-Sensitive and Iron Dextran-Tolerant Patients

     

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    Jur T. Strobos
    1400 Sixteenth Street, N.W.
    Suite 400
    Washington, DC 20036
    38.906861,-77.041385

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    1400 Sixteenth Street, N.W.
    Suite 400
    Washington, DC 20036


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