In the latest attempt to show a concerned Congress and the general public that it is taking action on drug shortages, FDA’s Center for Drug Evaluation and Research (CDER) has raised the organizational profile of its 11-member staff devoted to the subject, moving them into the Office of the Center Director.
FDA Drug Shortage Staff Gets Higher Profile As New Reporting Requirements Begin
The 11-member staff CDER devotes to drug shortages is moving to the Office of the Center Director and will report to Deputy Director for Regulatory Programs Doug Throckmorton.
More from United States
• By
Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.
• By
Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?
• By
As CMS administrator, Mehmet Oz will oversee the second year of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.
• By
The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.
More from North America
• By
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
• By
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
• By
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.