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
Major FDA Announcement on OTCs
As a first step, FDA has announced a March 25 and 26, 2014 public hearing to gather information and comments on the strengths and weaknesses of the current OTC monograph process, and to discuss ideas about modifications or alternatives. Following the meeting, FDA will accept written or electronic comments for consideration until May 12, 2014.
The notice of public hearing; request for comments is available here
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 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