Janet Woodcock
The legislation is pretty groundbreaking. The FD&C Act up until now has been practically silent, except for some of the...
The FDA Amendments Act transforms the drug safety system. In a recent address to the Food & Drug Law Institute, the acting head of the Center for Drug Evaluation & Research offered her view about what the law means and how the agency will make it work
Janet Woodcock
The legislation is pretty groundbreaking. The FD&C Act up until now has been practically silent, except for some of the...
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.