Office of New Drugs Director Peter Stein told sponsors during a panel discussion that they will be able to continue agreed upon development programs despite leadership changes arising from the OND reorganization; industry speakers excited, but also have some reservations, about the new OND.
For any sponsors wondering whether the Office of New Drugs (OND) reorganization would adversely impact their development programs with changes to division leadership, OND director Peter Stein sought to assure them that they can proceed with business as usual.
A multitude of leadership positions are opening within OND due to the reorganization's establishment of more therapeutically-focused divisions.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
