Federal Register notice: CBER announces a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Electronic Submission Tem...
Federal Register notice: FDA makes available a draft guidance entitled Non-Clinical Performance Assessment of Tissue Containment Systems Used During P...
An FDA advisory committee votes 9-3 to not recommend approval of an Acadia Pharmaceutical resubmitted sNDA for Nuplazid (pimavanserin) for an indicati...
FDA denies a petition from the Informed Consent Action Network asking that it not approve Covid-19 vaccines for youths ages 12-17.
An FDA annual report to Congress on drug shortages in 2021 identifies two supply chain needs that must be worked on.
A Health Affairs analysis from West Health Policy Center suggests two reforms for the Waxman-Hatch Paragraph 4 process that could speed the entry of g...
Draeger recalls (Class 1) one lot of its SafeStar 55 Breathing System Filter because a manual inspection process revealed that some defective filters ...
FDA grants Paratek Pharmaceuticals a fast track designation for an oral and intravenous formulation of its broad-spectrum antibiotic Nuzyra (omadacycl...