President Biden says his administration will invoke the Defense Production Act to manufacture essential medicines in the U.S. to mitigate drug shortag...
FDA and the Duke-Margolis Center for Health Policy announce a hybrid (online/in-person) public meeting 1/31 on Building Quality into the Design and Co...
Researchers say a hybrid pilot mock drug GMP inspection found that on-site investigators were able to interact with remote participants from national ...
FDA sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treating dry eye disease.
Novartis recalls two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottles.
Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications From Firms to Health C...
FDA withdraws its membership in the 32-member medical device Global Harmonization Working Party after failing to persuade the organization to align wi...
Federal Register notice: FDA sends to OMB an information collection extension entitled Good Laboratory Practice Requirements for Nonclinical Laborator...
