AAP endorses pediatric drug, device safety legislation
The American Academy of Pediatrics has commended the US Senate for passing the Food and Drug Administration Safety and Innovation Act and calls on the US House of Representatives to quickly pass companion legislation.
The American Academy of Pediatrics (AAP) has commended the US Senate for passing the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187) and calls on the US House of Representatives to quickly pass companion legislation.
The legislation passed by the Senate would reauthorize FDA user-fee programs and extend 3 laws that govern the safety and effectiveness of drugs and medical devices used to treat children.
The new law strengthens the Best Pharmaceuticals for Children Act, which promotes pediatric drug studies, and the Pediatric Research Equity Act, which requires that pharmaceutical companies conduct research on pediatric applications of adult drugs.
Major congenital malformations not linked to first trimester tetracycline use
November 22nd 2024A large population-based study found that first-trimester tetracycline exposure does not elevate the risk of major congenital malformations, though specific risks for nervous system and eye anomalies warrant further research.
