Sue Sutter

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

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation. The FDA will host three days of advisory committee meetings in mid-May. (Shutterstock)

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

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations. The FDA will build on its foreign unannounced inspections pilot program in India and China. (Shutterstock)

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

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population. The FDA heard a variety of advice on what to do with opioid postmarketing study results. (Shutterstock)

1 week ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems? Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts. Could states and the courts continue pro-vaccine policies even if the federal governments turn away from them?

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

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway. Ultragenyx's CEO pushed back on HHS Secretary Robert F. Kennedy Jr.'s assertion that the FDA is a sock puppet for industry. (Shutterstock)