Industry News Highlights:

June 2021 - 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.

New FDA Approval:
FDA approves Aduhelm (aducanumab) for treatment of Alzheimer’s using accelerated approval pathway

Updated FDA Guidance:
Emergency Use Authorization for COVID-19 Vaccines

New FDA Guidances Related to COVID-19:
Regulatory and Policy FAQ;
Master Protocols;
Remote Interactive Facility Evaluations;
ANDAs;
Container Closure Systems

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:
FDA has issued multiple guidances in the last year. CBR and our partner TruSubmit are up-to-date on all electronic submissions requirements! Visit our Services page or contact us.

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COVID-19:
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.