FDA issues guidance on "child" definition for PMAs (Pre-market Approvals):
This article was originally published in Clinica
Executive Summary
The FDA has issued a final guidance on premarket submissions for devices intended for children. Initially released in draft form in July 2003, the revised document now clarifies the distinction between state and federal law pertaining to the age of consent to the clinical definition of the paediatric population. It continues to define adolescent as aged 12 to 21, even though some paediatric devices include labelling that puts the upper age limit for a child at age 18. The FDA explained that its age descriptions are somewhat arbitrary, and that other factors, such as the weight, body size and physiological and neurological development, may be more appropriate indicators.
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.