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
Hogan Lovells Issues Sponsored Research Alert on Proposed Changes to Federal Policy for Protection of Human Subjects
The NPRM would substantially change, in several respects, the regulatory framework with which universities and research institutions have had years of experience. For example, if an institution receives federal funding for human subjects research, all clinical trials at the institution would become subject to the Common Rule. New rules would govern research use of biospecimens, and new elements of informed consent would prompt substantive and procedural modifications to current practice. The NPRM also implicates questions such as how institutions manage risk in multi-site studies if such studies are to be reviewed, as the proposal suggests, by a single Institutional Review Board (IRB).
To view the alert, please click here.
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