The International Council for Harmonization releases its Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals S1B(R1) with the ...
Federal Register notice: FDA announces its intent to prepare an environmental impact statement to evaluate the potential environmental effects of revi...
FDA releases summaries highlighting topics discussed at five GDUFA 3 reauthorization meetings.
The House Energy and Commerce Committee asks HHS to reverse the Trump administration's decision to remove FDA authority to require premarket review of...
The House Select Subcommittee on the Coronavirus Crisis announces a hearing that will take testimony next week from two Emergent BioSolutions top exec...
Two law students and a professor say whoever becomes FDA commissioner should commit to enforcing clinical trial transparency.
FDA advises pacemaker and other electronic implant device wearers to keep their cell phones, smart watches and other electronic devices at least six i...
FDA approves a Heron Therapeutics NDA for Zynrelef (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarti...