Pediatrics

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

The Cardiovascular and Renal Drugs Advisory Committee voted 10-6 that efficacy had been shown for the ultra-rare disease, but even panelists in the majority questioned whether the product satisfied the threshold requirement for an adequate and well-controlled study.

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.

The Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.

The US FDA Pediatric Advisory Committee uses web-posted reviews of “low safety risk” products to keep up with postmarketing monitoring requirements amid rising interest in pediatric development.

As amended, the Give Kids A Chance Act would renew the rare pediatric disease voucher program for five years and give the FDA new authority to bring enforcement action when pediatric studies are overdue. However, it would not remove the exemption from pediatric study requirements for non-cancer orphan drugs, which Democrats had sought. 

Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

Under current law, drugs or biologics must receive rare pediatric disease designation before 1 October to be eligible for a priority review voucher. The sunset provisions caused a spike in designation requests and a push by pediatric and rare disease advocates for an extension.

Sonio says its acquisition by global medical equipment company Samsung Medison is a wrap. Plans for the deal were announced earlier this year.

Newly published guidance that for the time first details how to use pediatric extrapolation and aims to decrease variations in regulatory expectations globally is now ready for implementation around the world.