About

Brian J. Malkin is a legal professional in Washington, District of Columbia, focusing on FDA regulatory matters and intellectual belongings regulation, especially patent litigation. His information on this intersection of regulation makes him a valuable partner to pharmaceutical, biotechnology, scientific device, and cannabis organizations as they navigate product improvement, market entry, and transactional possibilities. Brian Malkins practice covers a extensive range of FDA-regulated products, including tablets, biologics, scientific gadgets, cannabis, meals, nutritional dietary supplements, cosmetics, and tobacco products. He gives strategic guidance to customers for the duration of the product lifecycle, from premarket making plans to regulatory evaluate, advertising, enforcement, and publish-marketplace control. In unique, Brian advises on various aspects of drug development and patent techniques, such as pre-Investigational New Drug Applications (INDs), New Drug Applications (NDAs), orphan/area of expertise drug designations, Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs), 505(b)(2) NDAs, Risk Evaluation and Mitigation Strategies (REMS), Biosimilars, Medical Devices, Laboratory Developed Tests (LDTs), and combination drug/device products. He additionally has information in cannabis and hashish-derived merchandise, such as cannabidiol (CBD) products. Brian J. Malkins deep expertise of FDA rules and IP regulation, coupled together with his enjoy in patent litigation, positions him as a trusted guide to customers searching for to innovate, shield their intellectual property, and navigate the complicated regulatory panorama.

Legal Issues

Health Care Law

Gov & Administrative Law

Administrative Law, Election Law, Government Contracts, Government Finance, Legislative & Government Affairs

Intellectual Property

Patents

Patent Appeals, Patent Litigation, Patent Prosecution

Cannabis & Marijuana Law

Marijuana Business Formation, Medical Marijuana

Appeals & Appellate

Civil Appeals, Federal Appeals

Business Law

Business Contracts, Business Dissolution, Business Finance, Business Formation, Business Litigation, Franchising, Mergers & Acquisitions, Partnership & Shareholder Disputes

Certificates

No Certifications

Languages

Accepted Jurisdictions

Experience

• Partner
  McDermott Will & Emery LLP
  2020
• Senior Counsel
  McGuireWoods LLP
  2014
• Partner
  Frommer Lawrence & Haug
  2004

Education

Associations

Costs

• Free Consultancy Service

Location