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FDA OKs 2 Covid-19 Batches Made at Troubled Facility

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FDA allows Johnson & Johnson (Janssen) to use two batches, but not others, of its Covid-19 vaccine substance made at Emergent BioS...

Harvards Kesselheim is 3rd FDA Advisor to Resign

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Harvard medical school professor Aaron Kesselheim resigns from the agencys Peripheral and Central Nervous System Drugs Advisory Co...

Nuvo Remote Uterine Monitor Cleared

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FDA clears a Nuvo Group 510(k) for its InVu remote pregnancy monitoring platform that adds a new uterine activity module for remot...

Lilly Internal Investigation Finds No Wrongdoing

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An Eli Lilly investigation into whether a company executive altered manufacturing documents required by FDA finds no wrongdoing.

Blood Cell Separator Controls Info Collection

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Federal Register notice: FDA sends to OMB an information collection extension for a Class 2 special controls guidance on blood ce...

OPDP to Study Accelerated Approval Disclosures in DTC Ads

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The CDER Office of Prescription Drug Promotion solicits public comment on two proposed studies to examine accelerated approval dis...

FDA OKs Expanded Age Indication for Avita Medicals Recell

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FDA approves an expanded indication for Avita Medicals Recell thermal burn treatment system.

Stop Using Innova Covid Tests: FDA

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FDA says the public should not use the Innova SARS-CoV-2 antigen rapid qualitative test that has been recalled by the company for ...

Guide on Patient-reported Outcomes in Cancer Trials

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Federal Register notice: FDA makes available a draft guidance entitled Core Patient-Reported Outcomes in Cancer Clinical Trials.

FDA Extends J&J Covid Vaccine Storage Time

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FDA extends from 3 to 4.5 months the approved storage time for the Johnson & Johnson Covid vaccine.