FDA Matters blog author Steven Grossman urges the Senate HELP Committee to examine how FDA commissioner-nominee Heidi Overton intends to make regulatory decisions, including her commitment to scientific evidence, transparency and established agency procedures.
FDA warns Chatsworth, CA-based kdc/one Chatsworth about CGMP violations in its production of finished drugs.
FDA Matters blog author Steven Grossman urges the Senate HELP Committee to examine how FDA commissioner-nominee Heidi Overton intends to make regulatory decisions, including her commitment to scientific evidence, transparency and established agency procedures.
FDA warns Chatsworth, CA-based kdc/one Chatsworth about CGMP violations in its production of finished drugs.
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.
