About
Brian leads the company’s FDA regulatory groups. He has more than twenty years of meals and drug regulation exercise and over nine years of intellectual property law exercise. In particular, his exercise consists of the interrelation between patent law and meals and drug law. Brian’s regulatory experience consists of all sorts of FDA-regulated products: capsules (such as animal capsules), biologics, scientific devices, ingredients and nutritional dietary supplements, tobacco merchandise, and cosmetics. Brian’s highbrow assets experience consists of FDA and patent litigation for both innovator and universal organizations. Immediately previous to regulation college, Brian labored as a legislative correspondent in the U.S. Senate Committee on Labor and Human Resources. He commenced his prison profession as a regulatory counsel at the U.S. Food and Drug Administration, in which he labored for more than nine years in each the Office of the Commissioner and the Center for Drug Evaluation and Research. At FDA, he centered on new product critiques, compliance troubles associated with clinical investigations and intellectual belongings (e.g., patent time period healing). Brian’s work led to new product approvals as well as new enterprise steering documents and regulations, which includes the animal efficacy rule for counter-terrorism products. Following numerous years of exercise in an FDA law workplace, Brian diagnosed an unmet want to apprehend each meals-and-drug and intellectual-belongings regulation for lifecycle control and diligence, specifically regarding merchandise suffering from the Hatch-Waxman Act, inclusive of widely wide-spread and 505(b)(2) new drug applications. As a result, Brian returned to university to attain a Bachelor of Science diploma in biochemistry. Prior to joining McGuireWoods, he practiced for more than 9 years at an highbrow assets law office, where he labored on a variety of latest product evaluations, FDA and patent litigations, due diligence projects, patent prosecutions, and licensing and commercial transactions. › ›
Location
Legal Issues
- Health Care Law
- Gov & Administrative Law
- Administrative Law, Election Law, Government Contracts, Government Finance, Legislative & Government Affairs
- Appeals & Appellate
- Civil Appeals, Federal Appeals
- Business Law
- Business Contracts, Business Dissolution, Business Finance, Business Formation, Business Litigation, Franchising, Mergers & Acquisitions, Partnership & Shareholder Disputes
- Intellectual Property
- Patents
- Patent Appeals, Patent Litigation, Patent Prosecution
Costs
Certificates
Languages
Accepted Jurisdictions
Experience
- Senior Counsel
McGuireWoods LLP
2014 - Partner
Frommer Lawrence & Haug
2004
Educations
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