Alexandra B. Maulden
Associate
Alexandra (Alex) Maulden is an associate with Foley & Lardner LLP and a member of the firm’s Health Care Practice Group in the Boston office.
During law school, Alex was selected for the Mayo-Foley Health Law Fellowship, consisting of summer internships with the Mayo Clinic Legal Department in Rochester, Minnesota and Foley’s Boston office. During this time, she assisted attorneys at both the Mayo Clinic and Foley with a broad range of regulatory compliance and transactional matters. While in law school, she also interned with the Whistleblower Law Collaborative where she researched a variety of issues relating to health care fraud and abuse, with a specific focus on the Coronavirus Relief Fund.
Before law school, Alex was a clinical research assistant in the Emergency Department at Boston Children’s Hospital, where she coordinated with medical staff to identify eligible research study patients and discussed study procedures with patients.
Presentations and Publications
- Co-author, “FDA Clinical Investigations: New Guidance on Electronic Systems,” Health Care Law Today (November 20, 2024)
- Co-author, “Substance Use Disorder Treatment Services: 2025 Physician Fee Schedule Proposed Rule Would Expand Access and Medicare Coverage,” Health Care Law Today (July 29, 2024)
- Co-author, “Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans,” Health Care Law Today (July 25, 2024)
- Co-author, “New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers,” Health Care Law Today (April 25, 2024)
- Co-author, “FDA Issues New Warning Regarding Compounded Ketamine,” Health Care Law Today (October 26, 2023)
- Co-author, “Gender Affirming Care in Florida: Current Rules of the Road,” Health Care Law Today (August 23, 2023)
- Co-author, “Gender Affirming Care Restricted Under Missouri Bill,” Health Care Law Today (May 16, 2023)
- Co-author, “Florida’s Bill Targeting Gender Affirming Care Impacts Minors and Adults,” Health Care Law Today (May 9, 2023)
- Co-author, “FDA Publishes Framework for Digital Health Technologies in Clinical Trials,” Health Care Law Today (April 3, 2023)
- Author, “Ignoring the Experts: Implications of the FDA’s Aduhelm Approval” 48 American Journal of Law and Medicine 108-133 (July 11, 2022)
- Co-author, “United States,” The Healthcare Law Review (July 30, 2021)
- Author, “Wearables and the FDA: Lessons from the COVID-19 Pandemic,” DOME BLOG (June 28, 2021)
- Co-author, “11th Circuit FCA Ruling Takes Practical Approach to Materiality,” Law360 (July 8, 2020)
- Co-author, “Diagnostic Performance of C6 Enzyme Immunoassay for Lyme Arthritis,” Pediatrics (January 1, 2020)
- Co-author, “Positive 2-Tiered Lyme Disease Serology is Uncommon in Asymptomatic Children Living in Endemic Areas of the United States,” Pediatric Infectious Disease Journal (May 2019)
- Author, “Two-tier Lyme Disease Serology Test Results Vary By First-tier Test,” Pediatric Journal of Infectious Disease Society (February 22, 2019)
- Co-author, “C-Reactive Protein or Erythrocyte Sedimentation Rate Results Reliably Exclude Invasive Bacterial Infections,” The American Journal of Emergency Medicine (November 8, 2018)
- Co-author, “Accuracy of Clinician Suspicion of Lyme Disease in the Emergency Department,” Pediatrics (September 21, 2017)
FDA Clinical Investigations: New Guidance on Electronic Systems
On October 2, 2024, the FDA released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs.
Substance Use Disorder Treatment Services: 2025 Physician Fee Schedule Proposed Rule Would Expand Access and Medicare Coverage
On July 10, the Centers for Medicare & Medicaid Services released the Medicare Physician Fee Schedule Proposed Rule for the calendar year 2025.
Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans
On June 26, 2024, the U.S. Food and Drug Administration released draft guidance addressing use of diversity action plans in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry”
Monica Chmielewski and Alexandra Maulden Author Overview of FDA Diversity-Related Documents for Clinical Trials
Foley & Lardner LLP partner Monica Chmielewski and associate Alexandra Maulden highlight the key takeaways of several U.S. Food and Drug Administration (FDA) diversity-related guidance documents from 2016 onwards in their Applied Clinical Trials article, “An Overview of FDA Diversity-Related Documents for Clinical Trials.”
2024 Health Care & Life Sciences Top Trends
Foley & Lardner’s 2024 Health Care & Life Sciences Top Trends publication unpacks fast-moving developments to help your business.
New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers
The Office of Inspector General recently issued a new favorable advisory opinion regarding patient assistance programs for 12 specific disease funds.