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
CMS Releases Preliminary Code Decisions for Drugs, Biologicals and Radiopharmaceuticals
After the public meeting is held, CMS will consider the submissions and statements made at the public meeting. Final decisions are typically released on or about November 1.
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 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017