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Study Looks at FDA Regulation of Laboratory-Developed Tests

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Massachusetts General Hospital researchers say FDA policy deviations for regulatory laboratory-developed tests during the Covid-19...

Clozapine REMS Changes Effective 11/15

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FDA says changes to the clozapine REMS to ensure that the drugs benefits outweigh the risk of severe neutropenia take effect 11/15...

Moderna Says Data Support Booster Shot

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Moderna says an analysis of a Phase 3 study of its Covid-19 mRNA vaccine supports the usefulness of a booster shot.

Revised Guide on Ferric Oxyhydroxide ANDAs

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Federal Register notice: FDA makes available a revised draft guidance for industry entitled Draft Guidance for Ferric Oxyhydroxide...

Info Collection on Biosimilar User Fees

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Federal Register notice: FDA seeks comments on an information collection revision entitled Biosimilars User Fee Program.

AbbVie Files Rinvoq sNDA for Ulcerative Colitis

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AbbVie files a supplemental BLA for Rinvoq (upadacitinib) for treating certain adults with moderately to severely active ulcerativ...

FDA Approves Takedas Exkivity for Some Lung Cancers

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FDA approves Takedas Exkivity to treat specified non-small cell lung cancer patients identified that an approved diagnostic test.

ICH Guidance Combined: Validation of Analytical Procedures

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FDA says it has consolidated two ICH guidances and retitled them Q2(R1) Validation of Analytical Procedures: Text and Methodology.

FDA Releases Bad Ad Quiz

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FDA releases a quiz that participants can use to determine how much they know about prescription drug promotion and the Bad Ad pro...

FDA OKs Phase 1 Biomea IND Leukemia Trial

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FDA says Biomea Fusion can start a Phase 1 trial of its BMF-219 in some leukemia patients.