Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more. Allyson’s healthcare regulatory work ranges from clinical bioethics and informed consent issues to counseling on compliance with U.S. federal fraud, waste, and abuse laws such as the Anti-Kickback Statute, Stark Law, Sunshine Act, and their state law equivalents, as well as HIPAA, state healthcare privacy laws, change of ownership and state licensing requirements for various healthcare and healthcare adjacent entities.
Allyson also advises on development, drafting, and implementation of policies and procedures related to financial conflicts of interest, research misconduct, physician advisory board and consulting services agreements and other clinical research and commercial device compliance matters. She has advised numerous life sciences and healthcare entities, ranging in size from closely-held two employee pre-clinical start-ups, to large multinational publicly held entities with commercial products, on a variety of healthcare regulatory, privacy, and commercial matters, including various mergers, acquisitions, and private equity or venture capital investments, including IPOs, SPACs, and other corporate matters.
Allyson also provides advice to clients in the firm’s Cannabis practice, focusing on FDA and state regulation of products containing CBD, THC, & hemp, manufacturers and growers, and cannabis industry service providers, such as point of sale vendors and online marketplaces.
Prior to joining McGuireWoods, Allyson was associate general counsel and data privacy officer at a commercial-stage biopharmaceutical company and its pre-commercial subsidiary utilizing AI to identify& commercialize new drug candidates in neuroscience and immuno-oncology, and before that she served as associate general counsel & data privacy officer for a molecular diagnostics company located in New York and New Jersey. Allyson’s prior in-house experience allows her to bring a practical perspective to business and operational matters. Before moving in-house, Allyson served as senior associate in the Life Sciences-Healthcare Regulatory, Privacy & Cybersecurity, and Cannabis practices groups in the New York office of an AmLaw 50 firm.
“Spending time as in-house counsel means I have direct experience with the challenges regulated entities face. I bring a practical, business-minded perspective to the “gray areas” of regulatory compliance and risk assessment.”
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Hofstra University School of LawJDCertification in Clinical Bioethics
magna cum laude, Dean’s List, Dean’s Honor Scholar, Senior Associate Editor and Staff Member, Hofstra Law Review
2015 -
Missouri State UniversityBAEnglish, minor in Political Science
cum laude
2003
Member, American Health Law Association (AHLA)
- Speaker, Food and Consumer Product Litigation and Regulatory Update: Halloween Edition, October 30, 2024
- Speaker, Bioscience Business Innovation Program, MBA Candidates, Hofstra University, October 23, 2024
- Panelist, "The Emergence of Pharma Services and Life Sciences Investments," 17th Annual Healthcare Finance & Growth Conference, September 25 - 26, 2024
- Speaker, "Cannabis News," Consumer Product and Retail Brown-Bag Lunch Series, June 27, 2024
- Speaker, FDA Regulation of LDTs, June 26, 2024
- Moderator, "Pharma Services Investments: Preclinical/Clinical," 2024 McGuireWoods Healthcare Private Equity and Finance Conference, May 8, 2024
- Speaker, Food and Product Labeling and Sales Practices Litigation and Regulatory Update: March Radness Edition, March 21, 2024
- Speaker, Food and Product Labeling and Sales Practices Litigation and Regulatory Update: Halloween Edition, October 31, 2023
- Panelist, "Investments in Pharma Services," 16th Annual Healthcare Finance and Growth Conference, September 28, 2023
- New York
Selected for inclusion, “Best Lawyers: Ones to Watch,” Health Care Law, Woodward/White, 2023, 2025
- Author, Dairy Industry Alerted to New USDA Order Requiring National Raw Milk Testing, McGuireWoods Legal Alert, December 10, 2024
- Co-author, The Effects of AI on Healthcare Delivery, Chicago Medicine, November 2024
- Author, Key Takeaways From the 2024 Healthcare Finance and Growth Conference, McGuireWoods Legal Alert, October 15, 2024
- Author, State Scrutiny of Hemp Cannabinoids: California and Missouri Issue Bans on Intoxicating Hemp Products, McGuireWoods Legal Alert, October 2, 2024
- Author, Senior Living Alert: HIPAA Security Rule Compliance for Senior Living Facilities, McGuireWoods Legal Alert, July 26, 2024
- Author, Ounce of Prevention: Are You Keeping Track of Your Business Associate Agreements’ Requirements?, McGuireWoods Legal Alert, May 28, 2024
- Author, Ounce of Prevention: Do Your Business Associate Agreements Have All Required Provisions?, McGuireWoods Legal Alert, May 21, 2024
- Author, Ounce of Prevention: Do You Have Business Associate Agreements With Every Required Party?, McGuireWoods Legal Alert, May 14, 2024
- Author, Ounce of Prevention: Is It Time to Perform a Security Risk Assessment?, McGuireWoods Legal Alert, April 5, 2024
- Author, Interest in Psilocybin Continues to “Mushroom” for Potential Mental Health Treatment, McGuireWoods Legal Alert, April 1, 2024
- Author, The Effects of Artificial Intelligence on Healthcare Delivery, ABA Health eSource - February 2024 Vol. 20 No. 6, February 2024
- Author, California’s Prop 12 Fully in Effect, McGuireWoods Legal Alert, March 6, 2024
- Author, FDA Releases Final Quality Management System Regulation Amendments, McGuireWoods Legal Alert, February 8, 2024
- Author, Illinois Jumps on the Food Ingredient ‘Banned’ Wagon, McGuireWoods Legal Alert, January 31, 2024
- Author, FDA Publishes Two Key Guidance Documents on Cosmetics Facility Registration and Product Listing, McGuireWoods Legal Alert, January 26, 2024
- Author, 1st Circuit Rejects Convicted Former Medical Device Executives’ Off-Label “Free Speech” Theory, The FCA Insider, January 18, 2024
- Author, FDA Releases Its Scientific Support for Rescheduling Marijuana to Schedule III, McGuireWoods Legal Alert, January 18, 2024
- Author, Drug Enforcement Administration Signals Intent to Reschedule Marijuana, McGuireWoods Legal Alert, January 10, 2024
- Author, FDA Issues Draft Guidance on Providing Health Care Providers With Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, McGuireWoods Legal Alert, December 21, 2023
- Author, FDA Provides New Resource on Redundancy Risk Management Plans for Critical Food Manufacturers, McGuireWoods Legal Alert, December 21, 2023
- Author, FDA Warning Letter Declares Delta-8 and CBD Gummies ‘Adulterated Foods’, McGuireWoods Legal Alert, December 12, 2023
- Author, Homeland Security and HHS Release Interactive Healthcare Cybersecurity Toolkit, McGuireWoods Legal Alert, November 16, 2023
- Author, HHS Rescheduling, SAFER Banking Act May Change the Marijuana Landscape, McGuireWoods Legal Alert, November 14, 2023
- Author, FDA Proposes Brominated Vegetable Oil Ban, McGuireWoods Legal Alert, November 6, 2023
- Author, FDA Establishes and Solicits Nominations for Digital Health Advisory Committee, McGuireWoods Legal Alert, November 3, 2023
- Author, Pharma Services Industry Leaders Cautiously Optimistic: HCFG Conference Recap, McGuireWoods Legal Alert, October 19, 2023
- Author, HHS Proposes Updates to 20-Year-Old Public Health Service Policies on Research Misconduct, McGuireWoods Legal Alert, October 18, 2023
- Author, California Bans Four Common Food Additives and 26 Chemicals Used in Cosmetics, McGuireWoods Legal Alert, October 16, 2023
- Author, FDA Publishes New Guidance on Cybersecurity in Medical Devices, McGuireWoods Legal Alert, October 2, 2023