Federal Register notice: FDA releases a final guidance on using placebos and allowing blinding in cancer clinical trials.
AstraZeneca says that the Phase 3 TULIP 2 trial for anifrolumab, an investigational drug for treating systemic lupus erythematosus, met its primary en...
Stakeholders praise and criticize an FDA draft guidance on a benefit/risk assessment framewok for opioids.
An FDA safety alert recommends that healthcare providers transition to duodenoscopes with innovative designs that are more safe and eliminate the need...
FDA issues two final guidances explaining its views on making benefit/risk determinations for certain medical device approval applications.
FDA issues an FDA-483 with eight observations from an inspection at Dr. Reddys drug manufacturing facility in Andhra, Pradesh, India.
FDA grants Emalex Biosciences a fast track designation for its investigational drug ecopipam for treating patients with Tourette Syndrome.
FDA explains new requirements that are part of an upcoming switch to FAERS II that uses changes agreed to in an International Council for Harmonizatio...