Oct 20 (Reuters) - The US FDA on Tuesday issued guidance aimed at clarifying how drug companies can develop, distribute and ...
Following several recent initiatives, the FDA's newest rare disease framework sets out to standardize the agency's approach ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and ...
The tailored framework arrives amid renewed focus on rare diseases across US health agencies.
Major pharmaceutical companies are urging the US Food and Drug Administration (FDA) to adopt a more flexible, risk-based approach in its guidance on testing container-closure systems (CCS) for drugs ...
FDA finalized guidance on apps paired with prescription drugs, from inhaler trackers to dose reminders. Here is what it means ...
The FDA is codifying its regulations around mobile apps that go along with prescription drugs, offering a clearer framework ...
A two-day public workshop on evaluating robotic surgery systems with autonomous or remote capabilities is also on the agency’s agenda, as telesurgery advances globally.
Federal authorization, FDA enforcement discretion, and state market access are three separate questions. A product can lack FDA authorization yet fall within FDA’s current enforcement priorities, ...
Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...
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