Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have published a best practice guide for marketing authorisation applicants, covering multilingual packaging requirements for mutual recognition (MR) and decentralised procedure (DCP) products. Read more “Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?”

The Food and Drug Administration has finalised a guidance which will assist sponsors in designing and conducting non-clinical studies of investigational ERT products

Enzyme Replacement Therapy products are used to treat a wide range of metabolic disorders which have resulted from inherited defective genes (for example; Gaucher disease, Fabry disease or Pompe disease).

Read more “The Food and Drug Administration has finalised a guidance which will assist sponsors in designing and conducting non-clinical studies of investigational ERT products”

What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system

The US Food and Drug Administration (FDA) has been developing a new pharmaceutical quality assessment system known as the Knowledge-aided Assessment & Structured Application (KASA). Read more “What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system”

Have you seen the FDA’s guidance on child-resistant packaging statements in drug product labelling?

This guidance released by the United States (US) Food and Drug Administration (FDA) is intended to assist firms who choose to display child-resistant packaging (CRP) statements on their product’s labelling. Read more “Have you seen the FDA’s guidance on child-resistant packaging statements in drug product labelling?”