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Federal Register notice: FDA sends to OMB an information collection on medical device corrections and removals reporting.[ Price : $8.95]
A new Trump Administration initiative exempts laboratory-developed tests, including those for Covid-19, from the need to get FDA p...[ Price : $8.95]
FDA commissioner Stephen Hahn tells a Michigan TV station that the agency is not under any political pressure to speed approval of...[ Price : $8.95]
Ropes & Gray attorneys outline key provisions in an FDA final guidance on multiple function medical devices.[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says a TV ad for Xeris Gvoke fails to provide important risk information but misrep...[ Price : $8.95]
Bloomberg News says a Bayer product surveillance senior manager warned the company that FDA would be notice an increase in adverse...[ Price : $8.95]
FDA approves a Novartis NDA for Kesimpta (ofatumumab) for subcutaneous use to treat relapsing forms of multiple sclerosis.[ Price : $8.95]
FDA updates its alert on breast implant adverse events to include new reports received through 1/5 an increase of 160 new cases a...