FDA is seeking public input on cross-cutting policy issues to bring before the senior-level group, which is also facing the challenge of reviewing dozens of “breakthrough therapy” designation requests relevant to CDER-regulated products.
The CDER Medical Policy Council’s review of “breakthrough therapy” designation requests for specific products and indications marks a departure from the council’s charge to take a big picture approach to addressing broader, non-product-specific policy challenges.
Nevertheless, the task of reviewing the growing number of breakthrough requests has been handed to the council to ensure consistency...
Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.
The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.
US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.
The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.
The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.
After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?
Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.
