Overview
Attorney Bonnie Odom's experience includes the following:
- Conducting health regulatory due diligence for transactions involving life sciences companies
- Providing advice to pharmaceutical and device manufacturers on U.S. Food and Drug Administration ("FDA") compliance matters, including FDA premarket clearance and approval strategies and advertising and promotion issues
- Advising mobile app companies and other new entrants to the FDA-regulated environment in understanding and navigating applicable regulatory requirements
- Serving as legal counsel to the Combination Products Coalition (“CPC”), a group of leading pharmaceutical, device, and biologics manufacturers focused on regulatory issues impacting combination products
- Counseling hospitals and other health care providers in the areas of federal and state health care fraud and abuse issues, including anti-kickback and self-referral claims
- Assisting pharmaceutical companies in drafting and negotiating clinical trial agreements and maintaining clinical research compliance
- Advising clients on regulatory compliance related to the use of telehealth
Focus Areas
Services
Experience
Recognition
- The Best Lawyers in America©: “Ones to Watch” in Health Care Law (2024 to 2025)
Credentials
Media
Events
Insights
Insights
- PublicationsSolving the EDDO Guidance Puzzle1 minute read
- Firm Announcements
Epstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 2025
14 minute read - BlogsSharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft ...14 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession
12 minute read - Media CoverageBonnie Odom Quoted in “Health Care’s AI Embrace Boosts Workforce Despite Privacy Risks”2 minute read
- PublicationsCongress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs ...14 minute read
- PublicationsIn Vitro Diagnostic (IVD) Devices2 minute read
- Media CoverageLaw360 Names the 10 Epstein Becker Green Attorneys Who Moved Up the Ranks in 20222 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2022 Promotions6 minute read
- BlogsBuilding Compliance Programs for AI Tools3 minute read
- BlogsFDA Eases Device Modification Rules to Expand Availability of Ventilators During COVID-19 Pandemic6 minute read
- PublicationsOIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients' Travel, Lodging, and Other Expenses9 minute read
- BlogsWhat’s New in E-Cigarette Regulation?5 minute read
- BlogsThe Role of Patient Preference in Medical Device Evaluation4 minute read
- BlogsObscure FDA Device Reporting Exemptions Draw Patient and Provider Concern4 minute read
- BlogsFDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies5 minute read
- PublicationsResponse to RFIs: EBG Submits Comments to CMS on Stark Law Reforms and Is Preparing Comments to OIG on Anti-Kickback Statute ...8 minute read
- BlogsFDA Makes Moves to Advance Digital Health6 minute read
- BlogsNew Federal and State Initiatives Seek to Combat Antimicrobial Resistance6 minute read
- PublicationsUnderstanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between ...3 minute read
- BlogsWearables in the Workplace: Promise and Pitfalls6 minute read
- PublicationsFive Trending Challenges Facing Employers in the Technology, Media, and Telecommunications Industry28 minute read
- BlogsFCA Penalty Spike Confirmed by DOJ2 minute read
- BlogsHealth Care Providers May Soon See a Twofold Increase in False Claims Act Penalties5 minute read
- Firm AnnouncementsEpstein Becker Green Releases Comprehensive 50-State Survey on Telemental Health Laws in the United States6 minute read
- PublicationsUsing Social Media to Monitor Postmarket Drug Safety2 minute read
- Media CoverageBonnie Scott Featured in Q&A "Why 3D Printing Has 'Tremendous Potential' for Big Pharma"2 minute read
- BlogsFDA Leverages Patient-Reported Information to Monitor Drug Safety4 minute read
- Blogs3-D Printing Guidance Only a B-List Priority for FDA3 minute read
- PublicationsLegal Health: What's New in 3-D Printing?2 minute read
- BlogsWhat's the Latest in 3-D Printing?7 minute read
- PublicationsNIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations42 minute read
- Blogs3-D Printed Devices Pose Layers of Regulatory Questions5 minute read
- PublicationsFDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials13 minute read
- PublicationsRecent District Court Case Highlights State Variation in Applying Corporate Practice of Medicine and Global Billing ...9 minute read
- PublicationsDraft Framework for Interstate Medical Licensure Compact Released7 minute read
- Publications
The EYES Have it: Harnessing the Power of Eye Contact in the Workplace, on the Executive Women's Networking Blog ...
1 minute read - Publications
Proactively Approaching Telehealth Informed Consent, on the TechHealth Perspectives Blog
1 minute read - BlogsProactively Approaching Telehealth Informed Consent5 minute read
- PublicationsHow to Physically Secure Electronic PHI1 minute read
- BlogsPhysically Securing Electronic PHI in a Telehealth Environment6 minute read
- Publications
The Forecast for RAC Extrapolation: Mostly Cloudy, in Healthcare Financial Management
1 minute read - PublicationsOversight Overhaul: Eliminating the Premarket Review of Medical Devices and Implementing a Provider-Centered Postmarket ...1 minute read
- Publications
Provider Experiences with RAC Appeals Point to Opportunities for Program Improvement, in Healthcare Financial Management ...
1 minute read