FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated development, completing its PDUFA 7 commitments in this area.
Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to improve population health outcomes.
FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated development, completing its PDUFA 7 commitments in this area.
Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to improve population health outcomes.
The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by eliminating requirements that sponsors perform unnecessary tests.
A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involving bioanalytical method validation, study documentation and adherence to standard operating procedures at a facility in France.
