A House Energy and Commerce Health Subcommittee hearing discusses the need to legislatively reform FDAs oversight of laboratory-developed tests instea...
Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab) in combination with maintenance Lynparza (olaparib) did not meet its prim...
Abiomed recalls its Impella Left Sided Blood Pumps because the pump catheter may slice the hearts left ventricle wall during procedures.
FDA grants Elixir Medical a breakthrough device designation for its DynamX BTK System, an adaptive implant for use in treating narrowed or blocked ves...
Two SheppardMullin attorneys analyze a recent FDA draft guidance on informed consent and suggest steps that clinical trial sponsors, investigators, an...
FDA publishes a draft guidance on using non-interventional studies for drug and biological products to develop real-world evidence.
CBER launches a new Web page on its approach to using AI/ML in regulatory oversight of products it regulates.
