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;
Remote Interactive Facility Evaluations;
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
Read about these and more industry news highlights
CBR is maintaining business continuity during the COVID-19 pandemic.
Read about this and more CBR news highlights
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.