A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...
The Danish Medicines Agency has issued a list clarifying which clinical trial amendments will require approval by the DMA and which modifications can merely be notified to the agency 1 ,2 . The list has been issued in response to questions on the ...
The US Food and Drug Administration has expressed concern over the protracted negotiations it is having with the medtech industry over reauthorising its medical device user fee programme, minutes from a 2 August meeting between the FDA and industry ...
The US Food and Drug Administration is introducing two new training programmes to improve the consistency and skill of its medical device unit staff who review pre-market applications 1 . The programmes, designed for reviewers at the FDA?s Center ...
Health Canada has developed a "pre-application package" to help companies involved in the importation, distribution or wholesale of drugs prepare for an initial good manufacturing practice inspection 1 . The package is intended to be used by ...
The search functionality of Australia's online register of approved devices and drugs has been improved to enable industry, health professionals and consumers to find information on products more easily 1 ,2 . Changes to the Australian Register of ...
US medtech industry association AdvaMed is concerned about the US Food and Drug Administration ?s draft guidance on presenting risk information while promoting medical products because it is too heavily focused on prescription drugs 1 . The guidance ...
