On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 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FDA Issues Revised Draft Guidance on Reporting Drug Sample Information Under the ACA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 The draft guidance is available here.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.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
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