US FDA Center for Devices and Radiological Health (CDRH)

article

Economics and risks of FDA’s Quality management maturity rating programme

29 September 2022 | By Dr Clifford Rossi (University of Maryland)

Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…

news

New FDA medical device framework to improve women’s health

19 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.