THE TGA is inviting submissions on a new Provisional Approval pathway for prescription medicines, which will allow sponsors to seek a "time-limited provisional registration" of drugs that do not meet full clinical data requirements.
The pathway is intended for use where the potential benefits of earlier availability outweighs risks, with input required by 01 May.
See www.tga.gov.au.
The above article was sent to subscribers in Pharmacy Daily's issue from 21 Mar 17
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 21 Mar 17