G2G Bio Bulletin – May 4, 2026

Administration and Agencies

• FDA
  • The agency has announced two clinical trial initiatives. The first is standing up two proof of concept real-time clinical trials (RTCTs)with AstraZeneca and Amgen, where study data can be reported instantaneously to the agency. The stated purpose is to speed up timelines for early phase trials. The second is a request for information on how a pilot program using AI-enabled technologies can improve efficiency, speed, and quality of decision-making in such clinical trials. Comments are due May 29.
  • Following the departure of CBER Director Dr. Vinay Prasad, his deputy Dr. Katherine Szarama has been named as Acting Director, while the search process for a permanent appointee continues. She is an HHS veteran, having served at CMS and ARPA-H.
  • The FDA has announced a proposal, that would exclude anti-obesity medications from the 503B bulk drug substances list. Comments are due June 29.
• CDC
  • The Administration has filed an appeal to the March ruling from a federal district judge that halted the changes to childhood vaccination schedules and Secretary Kennedy’s appointments to the Advisory Committee on Immunization Practices (ACIP). The judge has declined to pause the case, while the appeal is being considered.
• White House, Other HHS Divisions & Departments:
  • 340B: Last week, HRSA formally indicated its opposition to a suit filed by three drug companies, alleging that the agency did not properly certify clinics who participate in the program.
  • Surgeon General: President Trump has withdrawn Casey Means’ nomination, and has named radiologist Dr. Nicole Saphier, the Director of Breast Imaging at Memorial Sloan Kettering Monmouth in New Jersey as her replacement. Dr. Saphier has ties to the MAHA movement, but unlike Means she has supported vaccination.
  • Global Health: The State Department’s efforts to reach a bilateral health agreement as part of its America First Global Strategy with Ghana have stalled, after officials in that country rejected health data sharing provisions in the deal. Similar issues have arisen with Zambia, Zimbabwe and Kenya. The stated aim of the strategy is to build more self-reliant, less aid-dependent health systems in recipient countries and bolstering disease surveillance.
  • Interagency Autism Coordinating Committee (IACC): This panel which directs autism R&D priorities, met last week for the first time after HHS Secretary Kennedy replaced 21 panel members, with his appointees earlier this year. The divided panel voted to recommend policy recommendations to Kennedy. This notably includes setting a standard definition of ‘profound autism’.