Regulatory News - June 2018
The EMA has released for public consultation a draft guideline on clinical evaluation of vaccines intended for the prevention of infectious diseases(Revision 1)
The FDA announced the availability of a guidance for industry entitled ''Clinical Trial Imaging Endpoint Process Standards. (IDRAC 274221)''. This guidance assists sponsors in optimising the quality of imaging data obtained in clinical trials. It is intended to support approval of drugs and biological products, where imaging is used to assess a trial's primary endpoint or a component of that endpoint.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly has adopted under Step 4 of the development process the Questions and Answers for the ICH S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals
The PRAC confirmed that the risks of the multiple sclerosis medicineZinbryta (daclizumab beta) outweigh the benefits for patients. Zinbrytaposes a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs. On 27 March 2018, the marketing the authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine. The press release can be found here.