Industry News Highlights:

January 2022 - FDA Virtual Town Hall series:
FDA continues its series of virtual Town Hall meetings for COVID-19 diagnostic test developers. Click here for meeting information.

FDA authorizes first oral antiviral treatment for COVID-19

FDA updates fact sheet on Janssen COVID-19 vaccine

FDA updates guidance on EUA for COVID-19 tests

FDA clears first 510(k) for a COVID-19 test

FDA advisory committee recommends EUA for COVID-19 vaccine in children aged 5-11

FDA amends EUA for COVID-19 vaccines
to expand use of single booster doses

FDA to withdraw temporary guidances/policies
for manufacturers of hand sanitizer, effective Dec. 31

FDA's Coronavirus Treatment Acceleration Program (CTAP):
CBR is currently assisting clients with COVID-19 development programs and we are very familiar with the Coronavirus Treatment Acceleration Program (CTAP). Please contact us if you need assistance or general advice related to this.

Regulatory Submissions in eCTD and Alternate Electronic Formats:
CBR and our partner TruSubmit are up-to-date on all FDA electronic submissions requirements! Visit our Services page or contact us.

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CBR is maintaining business continuity during the COVID-19 pandemic.

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Career opportunities at CBR:
Hiring the brightest and best! We need scientists with industry experience in vaccines and/or biotech. We are also hiring for various positions focused on regulatory affairs, clinical operations, and quality assurance.

Visit our Careers page to learn more about working at CBR and current job opportunities.