Dominick DiSabatino is a partner on the Life Sciences team in the firm's Washington, D.C. office.
Areas of Practice
Dominick’s practice focuses on complex FDA and healthcare regulatory, compliance and legal matters in the life sciences industry. Drawing from in-house secondments with clients of various growth stages, Dominick counsels pharmaceutical, biotechnology, cosmetics and medical device companies on critical business decisions spanning the entire product life cycle, from research and development to product launch and commercialization.
Dominick offers clients a deep knowledge of advertising and promotion of FDA-regulated products, organizational OIG compliance programs, labeling review and approval strategies, managed markets and payer interactions and privacy/data security concerns. He also advises his clients on matters regarding commercial contracting and supply chain logistics, clinical trial agreements, federal transparency obligations and interactions with FDA such as post-market adverse event and product complaint reporting, facility inspections and Form 483s. With his background in intellectual property law, Dominick identifies client issues related to patents, trademarks, copyrights and trade secrets.
Dominick is committed to pro bono service. He has counseled nonprofit organizations focused on health care integration and optimization and post-incarceration reentry programs. He also represented New York City's senior citizens in housing disputes and provided free speech advice for press operations in Africa.
More Legal and Business Bylines From Dominick DiSabatino
- FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information - (Posted On Wednesday, June 14, 2023)
- FDA Clarifies Approach to Pediatric Drug Development - (Posted On Tuesday, June 06, 2023)
- FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023 - (Posted On Sunday, June 04, 2023)
- Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway - (Posted On Wednesday, April 26, 2023)
- FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices - (Posted On Monday, April 10, 2023)
- FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer - (Posted On Wednesday, March 29, 2023)
- OIG Advisory Opinion Alert: Medical Flights for Patient Access - (Posted On Tuesday, March 07, 2023)
- CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs - (Posted On Wednesday, February 22, 2023)
- FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration - (Posted On Tuesday, February 14, 2023)
- FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization - (Posted On Wednesday, November 30, 2022)