R. Joel Slomoff
Norton Rose Fulbright US LLP
R. Joel SlomoffvCard
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Joel Slomoff has an international practice devoted almost exclusively to technology development and regulatory matters involving the Food & Drug Administration (FDA). He brings more than thirty years of private practice experience to the firm. He has counseled companies in the United States, Europe and Asia. Such enterprises include privately owned medium-sized to publicly held global businesses.
Joel's experience is far-reaching:
- He represents clients at all of the Centers within the FDA. Regulatory issues have been conducted primarily with the Centers for Biologics, Drugs, and Medical Devices.
- His experience and services provided at the Center for Biologics Evaluation and Research include such client issues as interferon, vaccines, and blood banks.
- At the Center for Drug Evaluation and Research, his experience covers such diverse products as cardio-renal, neuropharmacology, oncology, pulmonary, imaging, surgical, dental, anti-infective, anti-viral, generic and over-the counter drugs. He has also worked with emergency IND's.
- At the Center for Medical Devices and Radiological Health, he has worked with restorative, clinical laboratory, cardiovascular, respiratory, neurological, ophthalmic, reproductive, abdominal, ENT, dental and orthopedic devices. The new international medical device harmonization (STED) process is of special interest to many of Joel's medical device clients.
- He regularly assists his clients with inspections (QSIT), study audits (BIMO), IRB's, ethics, and other serious regulatory processes.
- The Clinical Laboratory Improvement Act (CLIA) has been of interest especially to clinical and analytical healthcare businesses.
- Outcomes-based regulatory policy is also of interest to him and many of his clients.
Mediation/Negotiation, Harvard Law School (Professor Frank Sander), 2006
JD, University of Maryland School of Law, 1968
BS, Biology, Wayne State University, 1965
In 1969, he was admitted to practice in the District of Columbia, and the United States Court of Appeals for the D.C. Circuit in 1970.
- District of Columbia Bar
- "Assessing Medical Treatment Outcomes with Medicare Data," FDLI Update, March/April 2006
- "FDA Prepares to Use Medicare Data in Assessing Medical Treatment Outcomes," SoCalBio Synergies, Summer 2005
- "Overcoming Challenges in Conducting Clinical Trials to Minimize Fraud and Abuse Claims During and After Trial," American Conference Institute, Chicago, IL, June 9, 2009
- "FDA/CMS Data Exchange and Policy Challenge," Navigating Drug & Device Safety in a Complex Regulatory Environment, Healthcare Business Women's Association (HBA) Conference, Washington, DC, November 14, 2006
- "Selection of Predicate Devices Affecting Patent Law," Intersection of FDA and Patent Law Conference, Food and Drug Law Institute (FDLI) Conference - Hatch-Waxman, Washington, DC, November 8, 2006
- Moderator, "Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA): Its Effect on Drugs, Biologics, and Medical Devices Patents," Intersection of FDA and Patent Law Conference, Food and Drug Law Institute (FDLI) Conference - Hatch-Waxman, Washington, DC, November 8, 2006
- "FDA: How it works and thinks!," University of Geneva School of Business, Geneva, Switzerland, February 20, 2006
- "What You Need to Know About FDA Inspections," Advanced Medical Technology Association Teleconference Series, Washington, DC, February 15, 2006
- "Reimbursement Considerations: Collaboration Between FDA and CMS," Introduction to Medical Device Law and Regulation, Food and Drug Law Institute (FDLI) Conference, Washington, DC, January 27, 2006
- "Joint FDA/SEC Activities," The American Conference Institute: Harmonizing the FDA/SEC Centralized Procedure for Referrals, New York, NY, January 18, 2006
- "New Medical Technology: FDA Requirements,” BioHouston Regulatory Affairs Roundtable, Houston, Texas, December 2005
- "FDA Regulatory Overview,” AO Foundation, Davos, Switzerland, September 2005
- American Bar Association
- Bar of the District of Columbia
- FDA Alumni Association, Charter Member
- Food & Drug Law Institute
- Regulatory Affairs Professional Society
- MIHO Museum, Supporter