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A new FDA report on Covid-19 activities notes that the agency is initiating a new inspection planning system that will be more eff...[ Price : $8.95]
A just-completed FDA inspection of Sun Pharmaceutical Industries Punjab, India manufacturing facility leads to a six-item Form FDA...[ Price : $8.95]
FDA sends India-based Cipla Ltd. a two-item Form FDA-483 after a recent inspection at its Madhya Pradesh, India manufacturing plan...[ Price : $8.95]
FDA revises a Pfizers emergency use authorization for Paxlovid (nirmatrelvir co-packaged with ritonavir) for treating mild-to-mode...[ Price : $8.95]
FDA clears a Visibly 510(k) for its Visibly Digital Acuity Product (VDAP), an at-home digital vision testing platform for determin...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Center for Devices and Radiological Health ...[ Price : $8.95]
Attorney Keeley McCarty warns medical device manufacturers that the government is pursuing False Claims Act cases against companie...[ Price : $8.95]
CDER researchers say they are developing a non-inferiority paradigm to assess exposure-response similarity between pediatric and a...