The Irish Medicines Board , having found no takers for a new service it started last year to offer formal scientific advice on the drug component of drug/device combination products, is planning to...
Health Canada has decided to put on hold a new product licensing requirement under which manufacturers of medical devices with a drug component were required to provide the Drug Identification Number...
The US Food and Drug Administration , responding to concerns over the lack of specific postmarketing safety reporting requirements for combination products, has issued a much-awaited proposed rule to...
The European Commission has formally adopted a new procedure that will allow small and medium-sized enterprises to use a new procedure for certifying their early quality and nonclinical data on...
