We advise on FDA regulatory policy, advocacy, and administrative disputes involving FDA decision-making. Our work spans rulemaking, guidance, and policy initiatives; citizen petitions and other regulatory submissions; exclusivity challenges; REMS disputes; and competitive-entry matters involving generic, 505(b)(2), and biosimilar products. We counsel brand sponsors, generic and biosimilar applicants, trade associations, and patient organizations.
A formal FDA submission may be appropriate when a stakeholder needs FDA to clarify, reconsider, or adopt a regulatory position; address a competitive approval issue; respond to a competitor's regulatory or commercial conduct; interpret statutory or regulatory requirements; or consider scientific, legal, patient, or public-health concerns.
We help clients assess whether these tools are right for the matter, how they fit within their broader regulatory and commercial strategy, and how to develop, draft, and present arguments that are legally persuasive, scientifically credible, and aligned with FDA priorities.
We advise on:
We advise on:
Alexander Varond has extensive experience advising on FDA policy, regulatory advocacy, and administrative disputes involving drug and biologic development, approval, exclusivity, and market entry. As former co-chair of Goodwin's FDA Litigation practice, Alex understands how to frame issues for FDA, how agency precedent develops, and how citizen petitions, public comments, white papers, and other advocacy tools can affect product approvals, labeling, exclusivity, competitive positioning, and agency decision-making. He has counseled sponsors, generic and biosimilar applicants, trade associations, and patient organizations on petitions, exclusivity contests, REMS issues, policy advocacy, and FDA-related legislation. When administrative work runs in parallel with litigation, Alex is accustomed to working alongside lead patent, antitrust, and litigation counsel as the FDA regulatory specialist.