Brian Mccormick Email & Phone Number

Tel-Aviv, Il

I am Teva's lead counsel on Research & Development and Regulatory legal and policy matters. My team and I serve as the regulatory legal professionals for our Global Innovative, Generic, Biologic, and Biosimilar businesses. We counsel on a wide range of matters through all phases of the product lifecycle, and provide strategic advice on the approval standards, exclusivities, opportunities, and challenges presented by the Food, Drug, and Cosmetic Act, the Public Health Service Act, and other laws. We provide legal and contractual support for all R&D activities, worldwide; counsel on the development and review of approved and promotional labeling; drive the creation of strategic regulatory filings such as citizen petitions, requests for formal dispute resolution, and informal correspondence; support regulatory litigation; and provide regulatory intelligence support. I currently serve on the Regulatory Affairs and Intellectual Property Leadership Teams, the Regulatory Strategy Board, the Labeling Review Board, and the Association for Accessible Medicines Implementation Team for GDUFA III, having worked directly with FDA to renegotiate the Agency's Commitment Letter under the Generic Drug User Fee Amendments.

Tel-Aviv, Il

Established a leading global regulatory policy and intelligence function with team members in five offices across four countries. Drove the development and successful execution of regulatory policy and advocacy strategies; fostered relationships with global health authorities; managed interactions with over a dozen innovator, biosimilar, and generic-side trade associations, worldwide; published daily and weekly regulatory intelligence newsletters; and organized monthly and quarterly networking and information-sharing regulatory policy meetings.

Brentford, Middlesex, Gb

Primary legal contact for Regulatory Affairs, Intellectual Property, and Research and Development clients, particularly on regulatory and lifecycle management issues. Counseled on wide-ranging issues under the Biologics Price Competition and Innovation Act, the FDA Amendments Act, the Medicare Modernization Act, the Hatch Waxman Act, the Orphan Drug Act, the Pediatric Research Equity Act, and the Best Pharmaceuticals for Children Act, among other laws. Served on global Regulatory Governance Board, Safety Strategy and Risk Management Advisory Panel, and US Labeling Committee.

Washington, Dc, Us

Associate and partner in industry-leading Pharmaceutical and Biotechnology Products regulatory practice, representing innovative pharmaceutical and biotechnology clients of all sizes. Assisted many clients with lifecycle management and advertising and promotion issues, including those under the False Claims Act and the Anti-Kickback Statute.

Juris Doctor, Law

Master Of Health Science, Health Policy

Ba, Government And History