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Massachusetts General Hospital researchers say FDA policy deviations for regulatory laboratory-developed tests during the Covid-19...[ Price : $8.95]
FDA says changes to the clozapine REMS to ensure that the drugs benefits outweigh the risk of severe neutropenia take effect 11/15...[ Price : $8.95]
Moderna says an analysis of a Phase 3 study of its Covid-19 mRNA vaccine supports the usefulness of a booster shot.[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance for industry entitled Draft Guidance for Ferric Oxyhydroxide...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled Biosimilars User Fee Program.[ Price : $8.95]
AbbVie files a supplemental BLA for Rinvoq (upadacitinib) for treating certain adults with moderately to severely active ulcerativ...[ Price : $8.95]
FDA approves Takedas Exkivity to treat specified non-small cell lung cancer patients identified that an approved diagnostic test.[ Price : $8.95]
FDA says it has consolidated two ICH guidances and retitled them Q2(R1) Validation of Analytical Procedures: Text and Methodology.