Sue Sutter

1 week ago | insights.citeline.com | Sue Sutter

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIPTracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines. A top FDA official questioned the safety of routine vaccination of adolescents at risk for mpox. (Shutterstock)

1 week ago | insights.citeline.com | Sue Sutter

Secretary Kennedy’s FDA Visit Included CDRH Stop, Speech Warning Of ‘Agency Capture’HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing. (Screenshot Of Senate Finance Committee Broadcast)

1 week ago | insights.citeline.com | Sue Sutter

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock SaysPlan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says. The reorganization proposal for the FDA is not a well-organized plan, former officials say.

1 week ago | insights.citeline.com | Sue Sutter

HHS’ Kennedy Warns US FDA Staff Against ‘Agency Capture’ By Industry, Special Interests HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing. HHS Secretary Robert F. Kennedy Jr. warned FDA staff about the impact of the "deep state" on agency oversight. (Shutterstock)

2 weeks ago | insights.citeline.com | Sue Sutter

US FDA Rare Disease Innovation Hub’s Goals Align With Trump, Leader Says The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress. The Rare Disease Innovation Hub is focused on driving consistency between CBER and CDER decisions. (Shutterstock)