Pediatrics

Among critics of Trump administration's moves, American Academy of Pediatrics says “White House event on autism was filled with dangerous claims and misleading information.”

“I knew when I was pregnant with my kids the first thing, I knew from just talking to my other friends, before you take anything when you're pregnant, you go to talk to your doctor. I think that's what most pregnant women do,” says regulatory attorney Christine Lawson.

Agency following what Commissioner Martin Makary says is President Trump’s instruction to “do what's medically right, to go bold and not worry about the corporations and the lobbyists.”

To supplement industry, MAHA’s “Make Our Children Healthy Again” Strategy Report stands out more for what it doesn’t say than what it does. Another omission is anything about HHS Secretary Kennedy’s focus on potential link between pregnant women’s use of acetaminophen and children's autism.

MAHA meeting announcement followed reports that HHS Secretary Robert F. Kennedy Jr. planned in September to release report on potential link to autism from pregnant women’s use of OTC acetaminophen.

NAD attorneys find Kendal Nutricare can continue using “natural” ad claims with limits for Kendamil formula but also conclude some research it submitted to support other claims wasn’t appropriate because the studies didn’t test its products.

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

President Trump's Executive Order creating the commission names mental health and weight-loss drugs as treatments of concern. But it does not mention vaccines, which Kennedy has criticized.

Hiya has more than 200,000 customers in the direct-to-consumer channel, all using subscriptions ordered on the brand’s website, and plans to expand into online marketplaces and retail chains. The startup “offers a compelling subscription model with attractive margins, profitability, and strong cash flow generation,” says USANA CEO Jim Brown.