FDA Counsels is a full-service legal, regulatory, and compliance consulting firm specializing in FDA-related matters, led by principal Steven A. Johnson. With over 30 years of experience, including prior roles as in-house counsel for pharmaceutical and device firms and as an Associate Chief Counsel for Enforcement at the FDA, the firm stands out for its deep regulatory insight and proven track record in navigating complex FDA legal challenges.
The firm adopts a strategic, lifecycle-oriented approach, offering tailored counsel to life sciences companies at every stage—from corporate formation and R&D to marketed products and crisis management. It focuses on delivering practical, business-aligned solutions, leveraging Mr. Johnson’s extensive background in FDA enforcement, litigation, and compliance to serve pharmaceutical, medical device, biotechnology, and related regulated industries.
Services Offered
- In-House FDA Counsel
- FDA Legal Services for Life Sciences Companies
- Clinical Research
- Advertising & Promotion
- Cosmetics Regulation
- Devices & IVDs
- Dietary Supplements & Functional Foods
- Food & Additives
- Drugs and Therapeutic Biologics
- OTC Drugs
- Crisis Management
- FDA Enforcement Representation
- Regulatory Strategy and Compliance
- Rx-OTC Switch Assistance
- New Drug Application (NDA) Strategy and Filing
- Pediatric Research Equity Act (PREA) Waiver Requests
- Recall Coordination
- Transactions Advisory
- Litigation Defense
- Representation before FTC, FDA, and NAD
Based in Southern California, FDA Counsels serves clients nationwide and is recognized for its expertise through industry lectures at forums such as the Food & Drug Law Institute and the Pharmaceutical Compliance Forum. Mr. Johnson is a recipient of the FDA Office of Chief Counsel’s Special Recognition Award, underscoring the firm’s commitment to excellence in FDA legal and regulatory practice.
