Approval, Labeling & Post-Approval Strategy

FDA strategy does not end with approval, and many post-approval issues are shaped by decisions made during review. Approved products generate continuing regulatory obligations and FDA-facing work that can directly affect patient access, product positioning, and long-term commercial value.

We provide senior FDA legal and regulatory strategy on post-approval matters where the regulatory, safety, labeling, and commercial stakes are highest. Where a matter calls for specialized operational or technical input, including pharmacovigilance operations, CMC, GMP, quality-system, or supply-chain expertise, we coordinate with the client's internal teams, consultants, or co-counsel.

We advise on:

• Supplemental approvals, including sNDAs, sBLAs, and new indications
• Postmarketing requirements and commitments (PMRs/PMCs), including modifications and FDA engagement
• Accelerated approval post-approval obligations, including confirmatory study strategy and withdrawal risk
• Labeling changes, including safety updates and labeling negotiations
• REMS strategy, modifications, assessments, and FDA engagement
• Drug shortage and discontinuance strategy, including 506C notifications
• Safety signals, safety-reporting issues, and FDA safety communications

Selected Experience

• Worked with brand sponsor on negotiating shared system REMS requirements, eligibility for a waiver, and implications of follow-on entrants.
• Helped client address critical drug shortages, including communication with FDA, and requests for allowances and flexibility during such shortage.
• Advised sponsor on post-approval strategy, including labeling updates, supplemental approvals for additional indications, manufacturing changes, and lifecycle planning around regulatory exclusivities.