How has FDA suddenly been able to enforce accelerated approval commitments in oncology? The agency’s Richard Pazdur reflects on lessons from 2021 – and promises more re-reviews to come.
The US Food and Drug Administration’s Oncology Center of Excellence is planning to make reviews of “dangling” or “delinquent” accelerated approvals a routine agenda topic for the Oncologic Drugs Advisory Committee to build on the momentum toward assuring timely confirmatory study results that it established in 2021.
“This is my Jihad,” OCE Director Richard Pazdur said during a Zoom panel discussion as part of the Prevision Policy/Friends...
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
