Comments on Q4B draft annexes due in October
This article was originally published in The Gold Sheet
The International Conference on Harmonization recently published two Q4B Step 2 annex documents under the topic "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. The draft annex 9 addresses tablet friability while draft annex 10 deals with polyacrylamide gel electrophoresis. The deadline for public comment on both is October 13
You may also be interested in...
The appointment of Belén Garijo as CEO of the German major from May next year is a small but significant step on the road to addressing gender inequality at the very top level of management in the world of big pharma.
The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.
Stada has named Yann Brun to become the group’s new head of global development, portfolio, regulatory and business development, replacing Robert Knerr. The move is the latest in a string of key appointments at Stada as the firm builds on a series of acquisitions and deals.