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FDAs Daunting Task to Tackle Misinformation: Califf

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FDA commissioner Robert Califf addresses the Reagan-Udall Foundation about its new report on misinformation and observes the agenc...

FDA Clears Home Hemoglobin Test

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FDA clears a Sanguina 510(k) for the AnemoCheck Home, a home-use hemoglobin test kit.

Panel Votes Down Amgens Confirmatory Study

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FDAs Oncologic Drugs Advisory Committee votes 10 to 2 that the CodeBreak 200 confirmatory study cannot be reliably interpreted as ...

Clinical Hold for Innate Lacutamab Trials

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FDA places a partial clinical hold on the Innate lacutamab IND to treat two forms of T-cell lymphoma following a patient death in ...

CDRH Marks 10 Years of Cybersecurity Program

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FDA touts the 10th anniversary of the CDRH cybersecurity program, highlighting several program achievements.

Reps Reiterate Call for VALID Act Passage

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Reps. Bucshon and DeGette call on Congress to pass the VALID Act in response to FDAs proposed rule on laboratory-developed tests.

Invitae Gets De Novo for Hereditary Cancer Panel

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FDA grants Invitae a de novo market authorization for its Common Hereditary Cancers Panel for identifying germline variants associ...

Panel on Blood Irradiator Into Class 3

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Federal Register notice: FDA is announcing an 11/7 Radiological Devices Panel of the Medical Devices Advisory Committee meeting to...

11 Covid-19 Product EUAs Revoked

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Federal Register notice: FDA announces the revocation of 11 Covid-related Emergency Use Authorizations after the authorization hol...

Stimulant Use Disorder Drug Development Guide

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Federal Register notice: FDA releases a draft guidance entitled Stimulant Use Disorders: Developing Drugs for Treatment.