Federal Register notice: FDA makes available a final guidance entitled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4.
Pfizer recalls branded and authorized generic lots of Accuretic tablets due to the presence of a nitrosamine above the acceptable daily level.
FDA warns Fort Lauderdale, FL-based ECI Pharmaceuticals about listing violations for two estrogen products that have been removed from the agencys onl...
Federal Register notice: FDA changes the name and function of the Bone, Reproductive and Urologic Drugs Advisory Committee to Obstetrics, Reproductive...
CDER Office of Policy for Pharmaceutical Quality director Ashley Boam details the Centers new experience with the ICH Q12 final guidance, which offers...
FDA says Adamis Pharmaceuticals is recalling four lots of Symjepi injection due to a potential manufacturing defect that could prevent dispensing the ...
Moderna says it will seek FDA emergency use authorization for its Covid-19 vaccine in infants 6 months to under 6 years old.
FDA warns Chinas Unimicro Medical Systems about multiple serious violations of Quality System regulations in its production of pneumoperitoneum needle...