The US Food and Drug Administration (FDA) agreed to a 60 day extension to the initial 90 day comment period. After 150 days of study, cogitation and debate, industry has filed comments. And the overwhelming response is that the draft guidance is unworkable.
“Rip it up and start again”, has been the over-riding response from the industry. In this video, Stephen Daniells looks at the main problem areas, and looks at the solutions being proposed.
FDA will now work its way through the comments, and there is no time limit on a response. We may hear something in six weeks, six months, or longer.
What the industry does not want is for the draft guidance to pass into regulatory limbo.
Video filmed and edited by Claire Videau.