Industry has criticised the way in which the US Food and Drug Administration is planning to amend the regulations on the pre-market approval (PMA) of medical devices to include requirements relating to the submission of data on paediatric subpopulations. The proposed and direct ...
Clinica
US FDA rules on submitting paediatric data draw industry concern
23 June 2010
Vibha Sharma
Not a subscriber ? Request a FREE Trial
Subscribe to Clinica
RELATED CONTENT
NEWS
Clinica News
- US FDA consults on fulfilling obligations for device post-market surveillance studies
- Australian health tech industries unite in criticism of reforms blueprint
- US HHS misses implementation deadline for transparency provision; drug, device firms concerned
- Health Canada seeks comments on regulatory proposals for radiopharmaceuticals
Other Informa News
Features & Analysis
Other Informa Analysis
EVENTS
19 March 2012
Montreux Convention and Music Centre, Switzerland
