ICH common technical document comments
In response to "several informal requests" from drug and biologic manufacturers, FDA extends to June 16 its comment deadline on the International Conference on Harmonization common technical document format draft guidance, published in September 2001 (1"The Pink Sheet" Sept. 10, 2001, p. 19)...
You may also be interested in...
Common technical document submission will remain voluntary, but recommended, according to FDA's draft guidance on general considerations regarding CTD submission.
In this week’s podcast, Medtech Insight's managing editor Marion Webb and deputy editor Reed Miller discuss highlights from the recent J.P. Morgan Healthcare and North American Neuromodulation Society (NANS) virtual meetings. London, UK-based reporter Barnaby Pickering profiles start-up CorWave SA, which developed a left ventricular assist device for treating end-stage heart failure.
Tom McLain tells how the new MCIT policy from the US Medicare agency – and winning support from Congress – will guarantee Medicare coverage for his company’s product, an artificial intelligence-enabled in vitro diagnostic platform.