CDER Office of Quality Surveillance director Jennifer Maguire explains the agencys surveillance testing and sampling program.
FDA tells Soleno Therapeutics that a change in study design for its Prader-Willi treatment NDA has the potential to answer agency questions about the ...
FDA issues a safety warning about certain brands of ultraviolet wands used for disinfecting surfaces because the devices may expose users and others t...
The Veeva Field Trends 2022 report says 75% of healthcare providers want contact with drug field staff to be a mix of digital and in-person.
FDA clears a Neuronetics 510(k) for a new indication for its NeuroStar Advanced Therapy for Mental Health device, a transcranial magnetic stimulation ...
FDA warns Spains Bioiberica about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns Imprimis Rx that professional promotional materials for a compounded ophthalmic drug make false and misleading statements about the drug.