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
FDA Issues Revised Draft Guidance on Reporting Drug Sample Information Under the ACA
To ensure comments are considered before work begins on the final version, comments on the draft should be submitted by October 9, 2014. The draft guidance is available here.
The author thanks Katelyn Ruiz for her assistance.
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