![Megan Robertson, healthcare lawyer, Epstein Becker](https://www.natlawreview.com/sites/default/files/styles/author_profile/public/images/megan%2520robertson%2520epstein%2520becker.jpg?itok=bh_cL3tJ)
Attorney Megan Robertson approaches her practice with enthusiasm that stems both from her personal experiences and her overall passion for the intersection of science, medicine, and the law.
Her background, including an undergraduate degree in genetics, allows her to understand the unique compliance challenges faced by, and the development opportunities available to, companies in the life sciences industry. These include drug and device manufacturers, clinical laboratories, research sponsors, clinical research sites, and contract research organizations (CROs), among others. Megan also coordinates due diligence efforts on behalf of private equity firms to perform risk-based regulatory and compliance assessments of investments in these types of businesses.
Because she has dedicated a substantial portion of her practice to the laboratory industry, Megan is a co-lead of Epstein Becker Green’s Clinical Laboratories Focused Initiative. She regularly advises lab clients and stakeholders on state and federal compliance considerations; in particular, Megan is experienced in guiding clients through the development of direct access testing business models, including aspects such as corporate structure, risk management, and regulatory compliance.
In addition to her life sciences practice, Megan has worked closely with providers of Applied Behavior Analysis (ABA) services to individuals with autism spectrum disorder and previously interned with the advocacy group Autism Speaks. From these experiences, Megan has developed an understanding of the issues related to ABA billing and coding compliance, as well as certain nuances of contracting to provide such services to both private and government payers.
Megan also enjoys working on different pro bono and volunteer initiatives. For example, she is actively involved in Legal Aid DC’s annual Making Justice Real Campaign and represents clients in hearings in front of the Social Security Administration as part of the appeal process to secure disability benefits.
More Legal and Business Bylines From Megan Robertson
- It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived - (Posted On Tuesday, April 30, 2024)
- Making Moves – FDA’s LDT Proposed Rule Sent to OMB for Review - (Posted On Thursday, March 07, 2024)
- FDA LDT Webinar Serves as a Reminder to Industry to Submit Comments on the Proposed Rule - (Posted On Friday, November 03, 2023)
- Diagnosing Health Care Podcast – Episode 70: Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs [Podcast] - (Posted On Thursday, September 28, 2023)
- FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors - (Posted On Tuesday, September 05, 2023)
- FDA’s LDT Proposed Rule Heads to the White House - (Posted On Tuesday, August 01, 2023)
- The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition - (Posted On Friday, May 20, 2022)
- Chevron Deference: Is It Time for Change? – Diagnosing Health Care [PODCAST] - (Posted On Tuesday, February 15, 2022)
- Federal and State Cannabis Rules Are Moving in Different Directions – Diagnosing Health Care [PODCAST] - (Posted On Thursday, June 03, 2021)
- FDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review - (Posted On Tuesday, July 28, 2020)