Content Type: Policy Interactions

Comments for Public Workshop, “Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15”

March 17, 2026

Comments on Draft Guidance, “Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics”

March 17, 2026

Comments on Draft Guidance, “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway”

March 17, 2026

Comments for Listening Session, “Joint USPTO-FDA Collaboration Initiatives” (Tu)

March 17, 2026

Comments on Proposed Rule, “Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting”

March 17, 2026

Comments for Listening Session, “Joint USPTO-FDA Collaboration Initiatives” (Van de Wiele)

March 17, 2026

Comments on Proposed Rule Implementing the Guarding US Medicare Against Rising Drug Costs (GUARD) Model

March 17, 2026

Comments on Proposed Rule Implementing the Global Benchmark for Efficient Drug Pricing (GLOBE) Model

March 17, 2026

Comments for Hearing, “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction”

March 17, 2026

Comments on Notice, “USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights”

March 17, 2026

Comments to the FDA Transparency Task Force

March 17, 2026

Comments on Notice, “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication” (Doshi et al.)

March 17, 2026