Keyword: Food and Drug Administration (FDA)
The panelists said the med's effects on the liver could be managed through labeling and education.
Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.
Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.
FDA officials developed the strategy to address the emerging cybersecurity threat and to incentivize device designers to focus on safety innovations.
Novocure wants to bring the electric field device to market in mesothelioma via the rarely used humanitarian device exemption.
GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.
The FDA rescinded its refuse-to-file letter two weeks after telling Alkermes it wouldn't even review the drug.
The FDA issued final guidance on developing and validating next-generation gene sequencing tests and a third draft guidance on in vitro diagnostics.
The FDA plans to allow firms to use abbreviated 510(k) conformity mechanisms to demonstrate all performance characteristics.
IDx developed the system, IDx-DR, to enable primary care clinics to assess whether patients with diabetes are at risk of vision loss.