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FDA Clears Home Hemoglobin Test

[ Price : $8.95]

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

Clinical Hold for Innate Lacutamab Trials

[ Price : $8.95]

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

[ Price : $8.95]

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

Reps Reiterate Call for VALID Act Passage

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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Federal Register notice: FDA releases a draft guidance entitled Stimulant Use Disorders: Developing Drugs for Treatment.

FDA Looking Into Counterfeit Ozempic: Report

[ Price : $8.95]

CBS News says a drug supply chain association issued an alert that FDA is investigating counterfeit Ozempic.

NextGen Portal Accepts OTC Monograph Files

[ Price : $8.95]

CDER says its NextGen Portal is now accepting Over-the-Counter Monograph Order Requests.