The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...
Morning Overview on MSN
Effort to end animal testing grows, but alternatives still fall short
Federal regulators in the United States are pushing harder than ever to reduce and eventually replace animal testing in drug ...
The Trump administration is redoubling its efforts to phase out animal testing in drug development and seeking to develop new ...
The FDA has released draft guidance aimed at helping drug developers shift away from traditional animal testing as the ...
The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...
Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency ...
In the fifth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss key considerations for biologics license applications (BLAs) and the Food and Drug ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance ...
In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
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