regulatory

News

FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.

News

Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.

Digital

Global HCP platforms are emerging as the new standard, offering a single place where professionals can find information, tools, and support.

News

New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.

News

Seeking a lead over rival Mineralys, AstraZeneca is using a priority review voucher for its US filing for uncontrolled hypertension drug baxdrostat.

News

Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.