In the six months since an executive order encouraged firms to provide early notification of potential shortages, FDA has prevented 128 of them, FDA Commissioner Hamburg reports. She attributes the success to manufacturers’ early notification of potential disruptions in drug supply.
FDA is touting the benefits of early notification of potential drug shortages as Congress moves forward with legislation to require such reporting.
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Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.
Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.
Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.
Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.
A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
