Rep. Sam Farr says Congressional Budget Office scoring problems prevent releasing FDA’s fiscal 2013 user fees from being held in the budget sequester, but an amendment will be proposed to ensure the agency’s fiscal 2014 fees are included in its appropriations.
The user fees FDA already lost to sequester likely will not be recovered, but members of Congress are expected to attempt to prevent the same result in fiscal year 2014.
Rep. Sam Farr, D-Calif., and congressional staff said following a June 5 subcommittee mark-up of the fiscal 2014 appropriations bill including FDA funding that the fiscal 2013 fees...
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
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.
