CDER director expresses concerns about lack of resources coupled with growing workload.
Center for Drug Evaluation and Research Director Janet Woodcock sounded an alarm about FDA's biosimilar program, warning it could "explode" from a potentially overwhelming workload and insufficient resources.
It suggests that user fees may not be enough to support the biosimilar program, which already has proven much more popular and labor intensive than expected.
Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.
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.
The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
