FDA postpones a 5/5-planned public meeting entitled Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027.
FDA commissioner Stephen Hahn says the agency staff is keeping up with user fee review activities but may have to cut back due to Covid-19 activities.
CVM warns two companies they are illegally distributing choloroquine phosphate products that are considered to be unapproved animal drugs.
Mayne Pharma files an NDA for E4/DRSP (estetrol and drospirenone), an oral contraceptive indicated for preventing pregnancy.
Three healthcare activists say FDA and NIH must start enforcing the FDAAA provision requiring clinical trial data to be submitted to ClinicalTrials.go...
Federal Register notice: FDA submits to OMB an information collection revision entitled Premarket Notification Procedures 21 CFR Part 807, Subpart E....
Federal Register notice: FDA sends to OMB an information collection extension for pediatric- uses of medical devices submissions.
Government and independent sources say FDA accepted a donation of millions of Bayer chloroquine tablets made in facilities in India and Pakistan never...