Frederick R. Ball

focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences and Medical Technologies industry group. Mr. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation. Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Finally, Mr. Ball helps companies maintain their trade secrets and competitive advantage through trade secrets litigation and enforcement of restrictive covenants. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.

He is admitted to the Massachusetts State Bar, Illinois State Bar, the Seventh Circuit and the U.S. Supreme Court. He is a 1996 cum laude graduate of Cornell Law School and a graduate of the University of Colorado at Boulder.

Resume

Experience

•Duane Morris LLP
- Partner, 2005-present
- Associate, 1999-2004
•DePaul University School of Law
- Adjunct Professor of Law, 2009-2013
•Holleb & Coff, Chicago, Illinois
- Associate, 1996-1999
•United States Army, 1985-1987

Honors and Awards

•Recipient of Lexology/International Law Office Client Choice Award for Healthcare & Life Sciences (Massachusetts), 2016
•Listed in Illinois Leading Lawyers, 2009

Publications

Selected Publications

•Co-author, FDA Takes Steps to Enhance Availability of Safe and Effective Face Masks, Duane Morris Alert, April 22, 2020
•Co-author, CARES Act Expands Immunity Protections for Covered Countermeasures and Healthcare Volunteers, Duane Morris Alert, April 13, 2020
•Co-author, CARES Act Package Ushers in Changes to OTC Drug Review Process, Duane Morris Alert, April 13, 2020
•Co-author, FDA Unveils Program to Expedite Coronavirus Treatments, Duane Morris Alert, April 1, 2020
•Co-author, FDA Guidance Aims to Accelerate Availability of COVID-19 Tests, Duane Morris Alerts, March 18, 2020
•Co-author, FDA's Report on CBD Reaffirms Status Quo, Duane Morris Alert, March 13, 2020
•Co-author, FDA Postpones Foreign Inspections Through April in Response to COVID-19, Duane Morris Alert, March 12, 2020
•Co-author, A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD, FDLI Update, Spring 2020
•Co-author, FDA Revises Policies and Procedures for Prioritization of ANDAs, Duane Morris Alert, February 6, 2020
•Co-author, FDA Provides Insight on Research and Drug Approval for Cannabis Products, Duane Morris Alert, January 24, 2020
•Co-author, Federal Minimum Age for Purchase of Tobacco Products Including E-Cigarettes Raised from 18 to 21, Duane Morris Alert, December 24, 2019
•Quoted in 'Supplement' On CBD Product Label A Bullseye For US Litigants, Says Attorney, The Rose Sheet, December 13, 2019
•Co-author, With a Flurry of Warning Letters and a Consumer Update, FDA Signals Commitment to CBD Enforcement Policy, Duane Morris Alert, December 2, 2019

•Co-author, FDA's Bark May Be Worse Than Its Bite: Revised Guidance Permits Certain Compounding of Animal Drugs from Bulk Drug Substances, Duane Morris Alert, November 25, 2019
•Co-author, U.S. Senators Urge Changes to Testing Requirements Under USDA Interim Final Rule for Hemp Program, Duane Morris Alert, November 22, 2019

•Quoted in “Regulatory Uncertainty Hangs Over Production of Industrial Hemp,” Agri-Pulse, November 20, 2019

•Co-author, In a Regulatory 'One-Two,' FDA Modifies Terms of Oversight Concerning Homeopathic Drugs, Duane Morris Alert, October 31, 2019
•Co-author, Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years, Duane Morris Alert, October 22, 2019
•Co-author, Discovery Ruling in District of Minnesota May Have Far-Reaching Implications for FCA Defendants, Duane Morris Alert, October 8, 2019
•Co-author, FDA's New Medical Device Rules Speed Up Review Process, Law360, October 2, 2019

•Co-author, DEA Announcement on Improving Access to Marijuana Research, Duane Morris Alert, September 3, 2019

•Co-author, OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations, Duane Morris Alert, August 27, 2019

•Co-author, CMS Issues Proposed Regulations to Expand Open Payments System Reporting, Duane Morris Alert, August 26, 2019

•Co-author, FDA Releases Guidance on REMS Modifications and Revisions, Duane Morris Alert, August 9, 2019

•Co-author, BYOD and eCOA: A Match Made in Heaven? FDLI Update, July/August, 2019

•Quoted, FDA Warns Curaleaf to Stop Marketing CBD with Unfounded Claims, Boston Globe, July 23, 2019

•Co-author, FDA Comments on the Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds and Extends Comment Period, Duane Morris Alert, June 24, 2019

•Co-author, How Will FDA Bring Order to the Wild West of Cannabis Regulations? Food and Drug Law Institute, June 10, 2019

•Co-author, FDA Releases Draft Guidance on Voluntary Recalls, Duane Morris Alert, May 13, 2018

•Co-author, FDA's Next Steps for Cannabis Products, Duane Morris Alert, April 4, 2019

•Co-author, AdvaMed's Updated Code of Ethics, Duane Morris Alert, February 12, 2019

•Co-author, Study Sponsors Take Heed: FDA Plans Changes to Expanded Access Program, Duane Morris Alert, Febuary 7, 2019

•Co-author, The 2018 Farm Bill Preserves FDA Right to Regulate Cannabis Products, Duane Morris Alert, February 4, 2019

•Co-author, FDA Issues Final Guidance on Data Integrity and Compliance with CGMP, Duane Morris Alert, January 14, 2019

•Co-author, DOJ Implements Granston Memo: Motions to Dismiss Filed in 11 False Claims Act Cases, Duane Morris Alert, January 3, 2019

•Co-author, FDA Announces New UDI Compliance Deadlines via Another Guidance Document, Duane Morris Alert, December 27, 2018

•Co-author, FDA Provides Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals, Duane Morris Alert, November 27, 2018

•Co-author, Redraft of 510(k) Third Party Review Program, Duane Morris Alert, November 8, 2018

•Co-author, CDER's New MAPP on Risk-Based Site Selection Model for Routine Inspections, Duane Morris Alert, November 7, 2018

•Co-author, SUPPORT Act Expands Sunshine Act Disclosure Requirements, Duane Morris Alert, October 25, 2018

•Co-author, FDA Unveils New Quality in 510(k) 'Quik' Review Program Pilot, Duane Morris Alert, October 22, 2018

•Co-author, Case Study: Jazz Pharmaceuticals v. Anmeal Pharmaceuticals, FDLI Update, October/November 2018

•Co-author, FDA Releases Revised Draft Memorandum of Understanding for Human Drug Compounding, Duane Morris Alert, October 1, 2018

•Co-author, FDA Publishes Draft Guidance Seeking Innovative Approaches for Nonprescription Drug Product Labeling and Additional Conditions for Use, Duane Morris Alert, August 8, 2018

•Co-author, FDA Publishes Draft Guidance for Field Alert Report Submission, Duane Morris Alert, August 7, 2018

•Co-author, Federal Circuit Confirms PTAB Decision Invalidating Certain Claims of Xyrem Patents, Duane Morris Alert, July 23, 2018

•Co-author, FDA Proposes to Amend Product Jurisdiction Regulations Without Any Significant Substantive Changes, Duane Morris Alert, June 12, 2018

•Co-author, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA, Duane Morris Alert, November 21, 2017

•Contributor, Duane Morris White Collar Criminal Law Blog
•Co-author, FDA Outlines Its Operation for Facility Evaluation, Duane Morris Alert, September 14, 2017
•Co-author, FDA Increases Priority Review Opportunities for Drug Products with Limited Competition, Duane Morris Alert, July 18, 2017
•Co-author, FDA Issues Draft Guidance on Pre-Submission Facility Correspondence - A Way to Reduce FDA Action Times for Priority ANDAs, Duane Morris Alert, July 14, 2017
•Co-author, FDA's Draft Guidance for Industry on 180-Day Exclusivity, Duane Morris Alert, March 1, 2017
•Co-author, FDA Issues Final Guidance on Quality Agreements in Arrangements for Contract Manufacturing of Drugs, Duane Morris Alert, January 3, 2017
•Co-author, FDA Issues Final Hatch-Waxman Regulations, Duane Morris Alert, October 7, 2016
•Co-author, FDA Issues Guidance on Self-Identification of Generic Drug Facilities, Duane Morris Alert, October 6, 2016
•Co-author, FDA Issues Draft Guidance on Data Integrity and Compliance with CGMP, Duane Morris Alert, May 3, 2016
•Co-author, FDA Publishes Draft Guidance on Abuse-Deterrence Testing of Generic Solid Oral Opioid Drug Products, Duane Morris Alert, April 22, 2016
•Co-author, FDA Implements Expedited Review of ANDA Submissions for 'Sole-source' Drug Products, Duane Morris Alert, March 31, 2016
•Co-author, FDA Proposed Rule on Fixed-Combination and Co-Packaged Drugs, Duane Morris Alert, March 16, 2016
•Co-author, Statutory and Regulatory Control for Drug Companies, Pharmaceutical and Medical Device Law, 2015
•Co-author, Generics, Bringing Your Pharmaceutical Drug to Market, April 2015
•Co-author, Chapter 11, Generic Drugs: ANDAs, Section 505 (b)(2) Applications, Patents, and Exclusivities, Food and Drug Law and Regulation, 3rd Edition, March 2015
•Co-author, FDA Issues Additional Guidances on Implementation of Drug Supply Chain Security Act, Duane Morris Alert, February 25, 2015
•Co-author, FDA Opens Plan to Let Generic Drug Manufacturers Update Labels to Debate, Duane Morris Alert, February 24, 2015
•Co-author, FDA Establishes the Office of Pharmaceutical Quality, Duane Morris Alert, February 23, 2015
•Co-author, FDA's Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection, Duane Morris Alert, December 23, 2014
•Co-author, Compounding Pharmacy Co-Owner Pleads Guilty to Misdemeanor Criminal Violations of the Food, Drug, and Cosmetic Act, Duane Morris Alert, December 22, 2014
•Co-author, FDA Policy Aims to Smooth Generic Access to Samples of Branded Drugs Subject to REMS Use Restrictions, Duane Morris Alert, December 16, 2014
•Co-author, FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS), Duane Morris Alert, December 1, 2014
•Co-author, FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act, Duane Morris Alert, November 17, 2014
•Co-author, FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA, Duane Morris Alert, November 10, 2014
•Co-author, DEA Releases Final Rule on Disposal of Controlled Substances, Duane Morris Alert, September 29, 2014
•Co-author, FDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings, Duane Morris Alert, August 11, 2014
•Co-author, FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA, Duane Morris Alert, August 4, 2014
•Co-author, FDA Issues Draft Guidance for Identification and Notification of Suspect Products, Duane Morris Alert, June 24, 2014
•Co-author, FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, Duane Morris Alert, June 20, 2014
•Co-author, FDA Seeks Information for Implementation of Drug Supply Chain Security Act, Duane Morris Alert, April 11, 2014
•Co-author, Chapter 8: Krelec et al. v. Mutual Pharmaceuticals Co., Inc., Top 20 Food and Drug Cases, 2013 & Cases to Watch 2014, January 2014
•Co-author, Statutory and Regulatory Controls for Drug Development, Chapter 1, Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2013 Cumulative Supplement, Bloomberg BNA, 2013
•Co-author, FDA's New Interpretation of the Five-Year NCE Exclusivity Provisions of Federal Food, Drug, and Cosmetic Act, Duane Morris Alert, February 26, 2014
•Co-author, FDA's Guidance for Industry Concerning Receipt Dates, Duane Morris Alert, February 14, 2014
•Co-author, FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs, Duane Morris Alert, July 17, 2013
•Co-author, CMS Lets the Sun Shine Down, FDLI Update, May/June 2013
•Co-author, FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing, Duane Morris Alert, June 18, 2013
•Co-author, CMS Publishes Physician Payment Sunshine Rules; Manufacturers and Group Purchasing Organizations Are Required to Submit Detailed Annual Reports, Duane Morris Alert, February 25, 2013
• United States v. Caronia: A Brief Look at the Broader Implications for the Food Industry, FDLI Update, March/April 2013
•Co-author, Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should Consider, Duane Morris Alert, March 6, 2013; republished in Healthcare Law360, March 19, 2013
• Federal Trade Commission vs. Watson: The Supreme CourtTakes Up 'Reverse Payments', Health Care Law Monthly, February 2013
•Co-author, FDA Suspends Sunland, Inc.; Major Peanut Butter Producer Hit with First Food Facility Suspension Under the Food Safety Modernization Act of 2011, Duane Morris Alert, November 30, 2012; republished by Life Sciences Law360, December 12, 2012
•Co-author, FDA Issues Guidance for Industry on Generic Drug User Fee Amendments of 2012: Q&A, Duane Morris Alert, August 29, 2012
•Co-author, FDA's Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013, Duane Morris Alert, August 8, 2012
•Co-author, Third Circuit Holds That Settlement Agreements Containing Payments from the Innovator to the Generic Challenger May Violate Antitrust Laws, Duane Morris Alert, July 23, 2012
• OIG for HHS Publishes Solicitation of Information and Recommendations for Revising Its Provider Self-Disclosure Protocol, Duane Morris Alert, June 22, 2012
•Co-author, CMS Delays Data Collection Under ACA's Physician Payments Sunshine Act to January 1, 2013, Duane Morris Alert, May 9, 2012
•Co-author, FDA Issues Draft Guidance on Affordable Care Act Prescription Drug Sample Transparency Program: Reporting Deadline Informally Extended to October 1, 2012, Duane Morris Alert, April 4, 2012
• Not Just the FTC Anymore: California's Top Court to Weigh In on 'Pay for Delay', GenericsWeb INNsight, March 2012
•Co-author, Affordable Care Act's Prescription Drug Sample Transparency Program Set to Go into Effect April 1, 2012, Duane Morris Alert, March 13, 2012
•Co-author, Supreme Court Addresses Whether Supremacy Clause Provides Private Right of Action to Challenge Medicaid Cuts in Douglas v. Independent Living Center, Duane Morris Alert, March 12, 2012
•Co-author, Centers for Medicare and Medicaid Services Releases Proposed Rule on Reporting and Returning of Overpayments, Duane Morris Alert, March 8, 2012
• FDA Issues Draft Guidance for Notification of Issues That May Result in Prescription Drug Shortage, Duane Morris Alert, March 1, 2012
• U.S. Court of Appeals for the District of Columbia Circuit Determines That FDA Warning Letters Are Not Final Agency Action, Duane Morris Alert, January 20, 2012
• FDA Issues Proposed Rule Regarding Citizen Petitions and PSAs Related to Section 505(b)(2) Applications or ANDAs, Duane Morris Alert, January 4, 2012
•Co-author, A Response to Terry Mahn's Is It Time for FDA to Revise Its Orange Book Rules to Deal with 'Skinny-Labled' Generic Drugs? FDLI's Food and Drug Policy Forum, December 14, 2011
• Federal Pre-Emption Under the Food, Drug & Cosmetic Act from Medtronic, Inc. v. Lohr; Pliva, Inc. v. Mensing, Bender's Health Care Law Monthly, September 1, 2011
•Co-author, U.S. Supreme Court Holds That State-Law-Based Failure-to-Warn Claims Are Federally Preempted Against Generic Drug Manufacturers, Duane Morris Alert, June 23, 2011
•Co-author, FDA's Guidelines for Petitions Filed Under Section 505(q) of Food, Drug, and Cosmetic Act, Duane Morris Alert, June 16, 2011
•Co-author, CMS: Proposed Rule for States on Medicaid Fee-for-Service Rate-Setting Procedures, Duane Morris Alert, May 12, 2011
•Co-author, FDA: Liquid OTC Drugs with Poorly Labeled Measuring Devices May Constitute Misbranding, Duane Morris Alert, May 10, 2011
• FDA's Interim Final Rules for the Food Safety Modernization Act, Duane Morris Alert, May 6, 2011
•Co-author, FDA: Processing and Reprocessing Medical Devices in Healthcare Settings, Duane Morris Alert, May 4, 2011
• FDA Requests Comments on Improving Regulatory Rules, Duane Morris Alert, May 3, 2011
•Co-author, Labeling Changes for Prescription Drugs After New Safety Information: FDA's Draft Guidance, Duane Morris Alert, April 28, 2011
•Co-author, Long-term Care Pharmacy Joint Venture May Violate Anti-kickback Laws: OIG Issues Advisory Opinion 11-03, Duane Morris Alert, April 20, 2011
•Co-author, FDA Drafts Pharma Industry Guidance for Postmarketing Studies and Clinical Trials, Duane Morris Alert, April 14, 2011
• Supreme Court Decides 340B Entities Cannot Sue Pharmaceutical Manufacturers for Noncompliance with Pharmaceutical Pricing Agreement, Duane Morris Alert, April 1, 2011
•Co-author, Pennsylvania District Court Prevents Disclosure of Hundreds of Confidential Settlement Agreements, Duane Morris Alert, March 24, 2011
•Co-author, FDA Announces Draft Guidance for Industry on User Fee Waivers, Reductions and Refunds for Drug and Biological Products, Duane Morris Alert, March 17, 2011

Speaking Engagements

Selected Speaking Engagements

•Speaker, Virtual Happy Hour with Update Magazine Authors Rick Ball and Justin Stern, Food and Drug Law Institute, April 30, 2020
•Speaker, How COVID-19 Is Affecting Life Sciences and Medical Technologies, Duane Morris Webinar, April 16, 2020
•Speaker, Food Enforcement and Compliance Conference, Food and Drug Law Institute, Washington D.C., March 26, 2020
•Moderator, The USDA Hemp Interim Final Rule: Status, Remaining Issues, and Next Steps, Food and Drug Law Institute, Webinar, January 21, 2020
•Speaker, Developments in Enforcement of CBD and Cannabis Products, FDLI's Enforcement, Litigation, and Compliance Conference, Renaissance Downtown Hotel, Washington D.C., December 11-12, 2019
•Speaker, Legal and Practical Issues in the Evolving World of Cannabis Regulation, Food and Drug Law Institute, Washington D.C., November 18, 2019

•Speaker, How to Free CBD from the FDA Grasp: Call It GRAS, The Cannabis Reporter Radio Show Podcast, May 20, 2019

•Speaker, Introduction to Drug, Biologics and Biosimilars Law and Regulation, FDLI's Introduction to Drug, Biologics and Biosimilars Law and Regulation, Boston, July 24, 2019

•Presenter, Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges, Food and Drug Law Institute, Webinar, May 14, 2019

•Panelist, Entering the U.S. Market: Considerations for Strategic Transactions and Collaborations, Innovation Across Borders: Strategies for Chinese Life Sciences Companies Doing Business in the U.S., Shanghai, March 7, 2019

•Moderator, Innovation Across Borders: Strategies for U.S. and Chinese Companies in the Health Sciences Industry, Duane Morris LLP and Chinese Biopharmaceutical Association (USA), January 8, 2019

•Speaker, Emerging Legal Issues in IP and Paragraph IV Litigation, GRx+Biosims Conference, Hilton Baltimore, Baltimore, Maryland, September 6, 2018

•Speaker, Recent FDA Guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, CBI Abuse-Deterrent Formulations Summit, Silver Spring, Maryland, March 13, 2018

•Speaker, Enforcement Throughout the Supply Chain, Food and Drug Law Institute, December 6, 2017

•Speaker, The FDA Reauthorization Act and GDUFA II: What You Need to Know, Food and Drug Law Institute, Live Webinar, November 14, 2017
•Panelist, Medical Products: FDA and Opioid Use, Food and Drug Law Journal Symposium, Washington D.C., October 20, 2017
•Speaker, Violations and Enforcement, FDLI Introduction to U.S. Drug Law and Regulation, Boston, June 15, 2017
•Speaker, Interpretation of the FDA Data Integrity Draft Guidance and Preparing for Compliance, Food and Drug Law Institute's Enforcement Conference, December 7, 2016
•Speaker, The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues, Food and Drug Law Institute's Introduction to Drug Law and Regulation Course: The Legal Framework for Drug Regulation, Washington, D.C., April 12-13, 2016
•Speaker, Recent Updates and Stories from the Trenches Pathways to Bringing Your Generic Drug to the U.S. Market: Paragraph IV Certifications, Hatch-Waxman Litigation, Section 505(b)(2), and the Biosimiliars Patent Dance, IP Life Sciences Exchange, Frankfurt, Germany, November 10, 2015
•Speaker, GDUFA Inspections, and Labeling, Oh My: A Look at the Regulatory Challenges and Opportunities for the Generic Industry Operating in the U.S. in 2015, World Generic Medicines Congress Europe 2015 Conference, Madrid, March 4-5, 2015
•Moderator, The Present Part 2: Generic Industry Challenges and Current Issues, Food and Drug Law Institute's Conference on Celebrating the 30th Anniversary of the Hatch-Waxman Amendments: The Past, Present and Future of Generic Drugs, Washington D.C., September 18, 2014
•Moderator, Doing Business With India: Latest Developments in Pharmaceutical Regulation, FDLI Webinar, June 27, 2014
•Presenter, Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation, The Food and Drug Law Institute, November 7, 2013
•Moderator, Practical Impact of Caronia and First Amendment Implications, Food and Drug Law Annual Conference, Washington, D.C., April 23, 2013
•Presenter, Violations and Enforcement, Food and Drug Law Institute's Conference on Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation, Washington, D.C., April 4, 2013
•Speaker, Hot Topics in Food, Medical Devices and Pharmaceuticals, Food and Drug Law Institute's U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation Conference, Sao Paolo, Brazil, September 10, 2012
•Speaker, American Health Lawyers Association and Food and Drug Law Institute's Conference on The Intersecting Worlds of Drug, Device, Biologics and Health Law, Washington, D.C., May 22, 2012
•Speaker, An Exploration of Current Professional Conduct Rules and Ethical Issues Raised by Lauren Stevens and Similar Cases, Food and Drug Law Institute's 55th Annual Conference, Washington D.C., April 25, 2012
•Speaker, Biosimilars: Viewing the New Guidances Through an International Lens, Food and Drug Law Institute Webinar, March 28, 2012
•Presenter, Introduction to Medical Device Law and Regulation: How the Government Regulates the Medical Device Industry, Washington D.C.. March 12, 2012
•Speaker, Food and Drug Law Institute's U.S.-China Food and Drug Law Conference, Beijing, June 2011
•Speaker, American Conference Institute Summit on Drug and Device Product Recalls, Philadelphia, March 2011
•Visiting Lecturer, University of Florida School of Pharmacy, Masters in Pharmacy, March 2011
•Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., November 2010
•Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., October 2009
•Speaker, Food and Drug Law Annual Conference, Washington, D.C., April 22-23, 2009
•Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., June 26-27, 2008
•Speaker, E-Discovery Ramifications of the Qualcomm Case, Webinar, March 18, 2008
•Speaker, Food and Drug Law Institute's Introduction to Drug Law, Import and Export Issues, January 19, 2007
•Speaker, Food and Drug Law Institute's Introduction to Drug Law, Enforcement, January 19, 2007