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
FDA Publishes Final Guidance on Physical Attributes of Generics
Our blog post about the December 2013 draft guidance is available here.
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