The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017
Preliminary Code Decisions Issued by CMS
Code applicants may submit materials responding to the preliminary decision and indicate their desire to make a presentation at the public meeting, but must do so by April 24, 2012. Additional preliminary code decisions for other types of products are expected to be issued by CMS in the next few days, so stay tuned!
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017