Clinical Trials
The FDA Commissioner wants sponsors to incorporate diversity into their development programs prior to Phase III.
As drug companies continue to explore the use of social media data to support their submissions, a panel of EU regulators have drawn up a seven-point action plan to help evaluate the usefulness and impact of such data in regulatory decision-making.
US FDA officials said dose optimization for rare diseases should not be sacrificed in the name of speeding access to medicines, but is the oncology approach spreading to rare diseases?
The International Council for Harmonisation has issued for comment draft guidance, which when finalized, is expected to provide the industry with flexibility to embrace non-traditional, innovative approaches in clinical trial design.