FDA sends India-based Cipla Ltd. a two-item Form FDA-483 after a recent inspection at its Madhya Pradesh, India manufacturing plant.
FDA revises a Pfizers emergency use authorization for Paxlovid (nirmatrelvir co-packaged with ritonavir) for treating mild-to-moderate Covid-19 to req...
FDA clears a Visibly 510(k) for its Visibly Digital Acuity Product (VDAP), an at-home digital vision testing platform for determining visual acuity.
Attorney Keeley McCarty warns medical device manufacturers that the government is pursuing False Claims Act cases against companies that promote off-l...
CDER researchers say they are developing a non-inferiority paradigm to assess exposure-response similarity between pediatric and adult patients.
The Sedgwick Recall Index says medical device recalls soared in the second quarter of 2022, while drug recalls remained level with the first quarter.
Federal Register notice: FDA makes available a draft guidance entitled Hydrogen Peroxide- Based Contact Lens Care Products: Consumer Labeling Recommen...
FDA lifts a partial clinical hold on the Curis TakeAim Lymphoma study of emavusertib.
