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 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is ...06 October 2016
On 1 September 2016, the European Medicines Agency ("EMA") opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the...08 September 2016