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Regulatory front for March 10, 2021

March 10, 2021

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Stimulus passes, no Medicare sequestration relief; OIG cites improper claims for polysomnography; Four senators seek feedback on Section 101 hangup.

BioWorld MedTech Briefs Regulatory Regulatory front U.S. CMS Patent

Free access to BioWorld coronavirus articles

BioWorld

The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak. Note that we have added three critical tables which are...

Today's news in brief

BioWorld

BioWorld briefs for May 7.

Single dose of Pfizer vaccine not strong enough against variants, U.K. study shows

BioWorld

LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of...

Next up, Novavax, after April’s vaccine woes and therapeutic failures

BioWorld

Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as...

Split vote at adcom for avacopan; FDA not Hy on Chemocentryx trial setup

BioWorld

The FDA’s Arthritis Advisory Committee panelists groped through cloudy data while complaining about the design of the phase III trial for Chemocentryx Inc.’s...