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Magellan Diagnostics recalls its LeadCare II, LeadCare Plus, and LeadCare Ultra blood lead tests due to concerns about false low r...[ Price : $8.95]
A panel of FDA staff from CDER and the Office of Regulatory Affairs provide the latest insights into common data integrity inspect...[ Price : $8.95]
CBER director Peter Marks announces he will immediately serve as Office of Vaccines Research and Review (OVRR) acting director, re...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on developing drugs for treating Nontuberculous Mycobacterial Pulmon...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device 510(k) Su...[ Price : $8.95]
Pfizer and BioNTech say they will seek in the coming weeks an emergency use authorization from FDA for their Covid-19 vaccine in c...[ Price : $8.95]
FDA issues a draft guidance on the use of two sources of real-world data to support regulatory decision-making.[ Price : $8.95]
FDA warns Condemned Labz that it is marketing misbranded unapproved new drugs.