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
NIH and FDA Announce Release of Draft Clinical Trial Protocol Template; Call for Comments by April 17, 2016
The template provides instructions and sample text that are intended to facilitate the preparation of consistent, organized, and complete protocols, so that clinical trials can be properly and more efficiently reviewed by the agencies. The template protocol follows the International Conference on Harmonisation E6 Good Clinical Practice guidance.
NIH and FDA request public comment on the draft template from investigators, investigator-sponsors, institutional review board members, and any other stakeholders involved in protocol development and review. The agencies are particularly interested in the utility of the template and the readability and clarity of the instructional and sample text. Comments will be accepted through April 17, 2016, but the announcement notes that comments will be used at the agencies’ discretion and responses to comments will not be provided. Draft template documents can be found here, and responses may be made here.
If you have any questions about the request for public comment from the NIH and FDA, please feel free to contact one of the Hogan Lovells authors of this blog post.
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