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FDA seeks advisory committee input on the benefits and risks of GRAIL's Galleri multi-cancer early detection test after two pivotal studies showed that the blood-based screening test detected about one-third of cancers diagnosed within 12 months of testing.
FDA seeks advisory committee input on the benefits and risks of GRAIL's Galleri multi-cancer early detection test after two pivotal studies showed that the blood-based screening test detected about one-third of cancers diagnosed within 12 months of testing.
Three major pharmaceutical industry associations urge FDA to revise its proposed distributed manufacturing rule to provide greater flexibility for existing multi-site manufacturing networks, clarify inspection and registration requirements, and avoid imposing additional regulatory burdens that could undermine drug supply-chain resilience.
FDA has issued a direct final rule updating its regulations to clarify that non-animal testing methods may be used, where appropriate, to establish the safety of drugs and biological products before human clinical trials.
