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An FDA complete response letter tells Liquidia the agency needs more CMC data on the companys LIQ861 inhalation powder to treat pu...[ Price : $8.95]
Federal Register notice: FDA posts a final guidance on its drug development tool qualification process.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex ...[ Price : $8.95]
FDA updates a CDRH Covid-19 guidance on notifying the agency of medical device discontinuance or shortages.[ Price : $8.95]
Two hospital-based doctors call on FDA to clear OTC hearing aids using the 510(k) pathway.[ Price : $8.95]
FDA clears a CorticoMetrics 510(k) for Thinq, its artificial intelligence-based software for use by radiologists and neurologists ...[ Price : $8.95]
FDA approves an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Hutchinson-Gilford Progeria Syndrome and proces...[ Price : $8.95]
FDA publishes a guidance for using bioburden reduction systems with dry heat to reuse certain filtering facepiece respirators.