James R. Johnson > Hogan Lovells US LLP > Washington DC, United States > Lawyer Profile
Hogan Lovells US LLP Offices
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON DC 20004
DISTRICT OF COLUMBIA
United States
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James R. Johnson
Work Department
Global Regulatory
Position
Partner
Career
Positioned at the forefront of Food and Drug Administration (FDA) compliance and regulatory issues critical to the business of life science companies, Jim Johnson excels at knowing what’s ahead.
He works with life science clients on FDA compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (GMP) requirements, data integrity responsibilities, import and export issues, and pharmacovigilance obligations. He helps clients around the world identify compliance risks early, prevent problems from happening, efficiently resolve issues with minimal corporate pain, and improve agency relationships.
Jim knows the FDA well. Prior to joining Hogan Lovells, he served as Associate Chief Counsel for Enforcement in the FDA’s Office of the Chief Counsel. He handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components, particularly the FDA’s Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research’s (CDER) Office of Compliance.
Whether preparing an international manufacturing site for an FDA inspection, or working with a U.S.-based facility in response to FDA inspectional observations (a Form FDA 483), Jim uses his extensive agency and private practice experience to assist pharmaceutical, biotechnology, and cosmetic companies worldwide. He regularly conducts GMP assessments and investigations, resolves warning letters and import alerts, and appears in front of the FDA on behalf of companies to resolve enforcement actions.
Jim also advises life science companies on drug approval and life-cycle management strategies, and represents clients in related litigation against the FDA and U.S. Patent and Trademark Office. Jim honed these skills at the FDA, where he defended the agency in Hatch-Waxman cases involving agency exclusivity and patent-term extension determinations.
Education
J.D., Marquette University Law School, 2005
B.S., Molecular Biology and Genetics, University of Wisconsin-Madison, 2002
Top Tier Firm Rankings
- Transport > Aviation and air travel: litigation and regulation
- Antitrust > Cartel
- M&A/corporate and commercial > Corporate governance
- Media, technology and telecoms > Cyber law (including data privacy and data protection)
- Industry focus > Education
- Government > Government relations
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- Dispute resolution > Product liability, mass tort and class action - defense: consumer products (including tobacco)
- Transport > Rail and road: litigation and regulation
- Real estate > Real estate investment trusts (REITs)
- Media, technology and telecoms > Telecoms and broadcast: regulatory
- Media, technology and telecoms > Telecoms and broadcast: transactions
- International Trade > Trade remedies and trade policy
Firm Rankings
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- International Trade > CFIUS
- International Trade > Customs, export controls and economic sanctions
- Labor and employment > Employee benefits, executive compensation and retirement plans: transactional
- Energy > Energy regulation: oil and gas
- Environment > Environment: litigation
- Environment > Environment: regulatory
- Government > Government contracts
- Healthcare > Health insurers
- Healthcare > Life sciences
- Healthcare > Service providers
- Tax > US taxes: non-contentious
- Insurance > Advice to insurers
- Dispute resolution > Appellate: courts of appeals / Appellate: supreme courts (states and federal)
- Finance > Capital markets: debt offerings
- Finance > Capital markets: equity offerings
- Finance > Capital markets: global offerings
- Energy > Energy regulation: electric power
- Finance > Fintech
- Labor and employment > Immigration
- Dispute resolution > International litigation
- Tax > International tax
- M&A/corporate and commercial > M&A: large deals ($1bn+)
- Antitrust > Merger control
- M&A/corporate and commercial > Shareholder activism
- Finance > Structured finance: derivatives and structured products
- Media, technology and telecoms > Technology transactions
- M&A/corporate and commercial > Venture capital and emerging companies
- Antitrust > Civil litigation/class actions: defense
- Energy > Energy litigation: oil and gas
- Finance > Project finance
- Energy > Renewable/alternative power
- Finance > Restructuring (including bankruptcy): corporate
- Finance > Project finance
- Dispute resolution > International arbitration
- Finance > Financial services regulation
- Investment fund formation and management > Private equity funds (including venture capital)