Content Type: Policy Interactions

Comments on Draft Guidance, “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules”

March 17, 2026

Comments on Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights

March 17, 2026

Comments for Hearing, “Administering the Hatch-Waxman Amendments: Ensuring an Appropriate Balance Between Innovation and Access” (Luo)

March 17, 2026

Comments for Hearing, “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products”

March 17, 2026

Comments for Listening Session, “Optimizing FDA’s Use of and Processes for Advisory Committees”

March 17, 2026

Comments on Proposed Criteria for “First Generic” Submissions for Purposes of ANDA Review Prioritization Under GDUFA

March 17, 2026

Comments on Draft Guidance, “Expedited Program for Serious Condions-Accelerated Approval of Drugs and Biologics”

March 17, 2026

Comments on Implementation of Executive Order 13937, “Executive Order on Access to Affordable Life-Saving Medications.”

March 17, 2026

Comments on Proposed Rule, “Discrimination on the Basis of Disability in Health and Human Services Programs or Activities”

March 17, 2026

Comments for Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee

March 17, 2026

Additional Comments on Proposed Rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”

March 17, 2026

Comments on Draft Guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework”

March 17, 2026