Pediatrics
A Senate report finds GSK’s withdrawal of Flovent and shift to an authorized generic increased costs, restricted access and disrupted asthma care, while helping the company avoid Medicaid rebates, raising broader concerns over pricing loopholes.
Clinigen's CEO and senior executives outline how the services company navigated Japan’s rigorous regulatory framework to secure approval for Prolacta’s human milk–based fortifier as a prescription biological product.
The European Medicines Agency’s review of its stepwise pediatric investigation plan pilot, which allows sponsors in justified cases to finalize core study details later in development, found that the approach was both feasible and valuable in supporting complex pediatric drug development programs.
When FDA warned Agebox about selling iKids-Growth IGF-1 Support supplements as unapproved drugs, agency along with CDC had for around a month been investigating outbreak of infant botulism linked to ByHeart formula.
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.