FDA's Høeg plans to scrutinize SSRIs, RSV shots for babies
statnews.com • • business
Key Points:
- Tracy Beth Høeg, the new top drug regulator at the FDA, announced her intention to closely examine the safety of antidepressants and RSV protection shots for infants.
- Høeg emphasized the need for improved safety monitoring of antidepressants used by pregnant women, noting that current oversight has been insufficient.
- She highlighted monoclonal antibodies protecting infants from RSV as another priority area for enhanced evaluation.
- Høeg expressed optimism about internal agreement within the FDA's Center for Drug Evaluation and Research (CDER) on the need for better safety assessments in these areas.
