The FDA this week released a new draft guidance encouraging the inclusion of male patients in breast cancer clinical trials, the incidence of which has increased approximately 26% over the last 25 years.
US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.
As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for ‘economic stability’ and to bring affordable drugs to patients.
Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.