The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
HHS Seeks Comments on Transfer of IRB Oversight Draft Guidances
The guidance documents address the following topics:
- Regulatory background for research project transfer;
- Transfer of oversight of a research project from an internal IRB to an external IRB, or an external IRB to another external IRB, when the project remains at the same institution;
- Transfer of oversight of a research project from one internal IRB to another internal IRB; and
- Transfer of oversight of a research project when the project is transferred to a newly engaged institution.
Both draft guidance documents recommend that the transfer process use a written agreement between the original and receiving IRBs that covers a number of specific items, such as the date of transfer, record retention, and whether consent forms need revision.
Comments are due by August 13, 2012. FDA and OHRP intend to work together in developing final guidances to ensure harmonization.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017