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
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
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