ICH harmonizing more compendia
This article was originally published in The Gold Sheet
The International Conference on Harmonization said it made major progress on pharmacopoeial harmonization of the U.S., EU and Japan at its Oct. 24-29 meeting in St. Louis, Mo. ICH Q4B annexes for dissolution, tablet friability and polyacrylamide gel electrophoresis reached step 4 of the ICH process. Meanwhile, annexes for capillary electrophoresis and analytical sieving reached stage 2
You may also be interested in...
Data show Opdivo/Cabometyx combo bests Sutent for overall and progression-free survival and response endpoints in first-line RCC. Exelixis CEO says comparison to Sutent is standard control and allows better comparison to other combo regimens.
ES: Public Company Edition: Fifty biopharma companies launched initial public offerings in the US last year and there have been 52 so far in 2020, including Metacrine, Dyne, Athira and COMPASS.
In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.