The Justice Department says Mallinckrodt is paying $15.4 million to resolve allegations that it paid illegal kickbacks to doctors to induce Medicare A...
BioCentury identifies the names of three potential FDA commissioner candidates sent to the White House.
Former CDER associate director for genomics Felix Frueh joins NDA Partners as an expert consultant, and former FDA chief of staff Lauren Silvis joins ...
FDA clears a medPhoton 510(k) for the ceiling-mounted ImagingRing, an in-room cone-beam computed tomography imaging system.
FDA clears an Arthrosurface 510(k) for its BOSS Toe Fixation System for stabilizing the first metatarsal that presents with a distal bone void.
Three stakeholders suggest changes to an FDA draft guidance on instructions for use in combination product labeling.
A Pew Charitable Trusts issue brief says there are not enough new antibiotics in the development pipeline to meet the need.
Federal Register notice: FDA has submitted to OMB an information collection extension for positron emission tomography Drug GMPs.