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Trump to Lower FDA Approval Standards: ex-Pfizer Exec LaMattina

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Former Pfizer Global Research and Development president and Forbes contributor John LaMattina believes FDA will lower its approval...

2 Outdated Proposed Rules on Gene Therapies and Crabmeat Withdrawn

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Federal Register Notice: FDA withdraws two proposed rules published over five years ago because they are outdated.

Thermo Fisher PMA for Lung Cancer Assay

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Thermo Fisher Scientific files the final module of a PMA for its Oncomine Universal Dx Test, a multi-gene, next-generation sequenc...

FDA Wants eSubmissions to Conform to Data Standards

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FDA says it has amended its electronic submission Technical Rejection Criteria for Study Data to require study data standards in c...

FDA Rejects Dynavax BLA on Heplisav-B

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FDA sends Dynavax Technologies a Complete Response Letter on its BLA for Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)...

FDA Clears CapsoVision Capsule Endoscope

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FDA clears a CapsoVision 510(k) for the CapsoCam Plus small bowel capsule endoscope system.

Debarment Order Against Edward Manookian

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Federal Register Notice: FDA issues a debarment order against Edward Manookian (also known as Ed Manning) based on a finding that ...

Novartis Gains Priority Review for Midostaurin in Leukemia

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FDA grants Novartis a priority review for an NDA for midostaurin, indicated for treating acute myeloid leukemia in newly-diagnosed...

Celebrex Passes FDA-ordered Safety Study: Pfizer

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Pfizer says that an FDA-ordered safety study of Pfizers arthritis drug Celebrex (celecoxib) demonstrated similar rates of cardiova...

Comments Sought on Biologic Deviation Reporting Extension

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Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection on the Reporting of Biologica...