The ICH says its S11 guideline on safety testing supporting pediatric drug development has reached Step 4 of the approval process.
Federal Register notice: FDA sends to OMB a proposed information collection entitled FDA Advisory Committee Membership Nominations.
FDA warns a Web site that it is selling unapproved and misbranded new drugs as a treatment for Covid-19.
FDA approves a UroGen Pharma NDA for Jelmyto (mitomycin gel), indicated for treating low-grade upper tract urothelial cancer.
FDA grants emergency use authorizations to two Covid-19 antibody tests.
Viveve Medical says it has resubmitted an IDE to FDA for approval to conduct the PURSUIT trial of its CMRF treatment for stress urinary incontinence.
Five drug stakeholders comment on a recent FDA/FTC workshop on building a competitive marketplace for biosimilars.
Federal Register notice: FDA withdraws a 3/6 Federal Register notice on a proposed information collection entitled Food and Drug Administration Safety...