The head of the European Medicines Agency’s scientific advisory office is hopeful that the organization’s PRIME initiative will be enshrined in EU legislation over the coming years, rather than just existing as an initiative from the agency.
The European Medicines Agency is aware that its US counterpart, the Food and Drug Administration, offers a “much higher variety” of early support mechanisms for sponsors, but it is aiming to support companies as much as it can, according to the head of the agency’s scientific advisory office, Iordanis Gravanis.
During an interactive EMA event, Gravanis noted that while the EMA does not have as many mechanisms in place to facilitate these early
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
