"What" Series

What types of drugs are regulated by CBER?

6 December 2023
2 min read

CBER, or the Center for Biologics Evaluation and Research, is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services (HHS). CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. 

Neumora Therapeutics Reveals FDA Approval for NMRA-266 Investigational New Drug and Commences Phase 1 Human Trials
Latest Hotspot
3 min read
Neumora Therapeutics Reveals FDA Approval for NMRA-266 Investigational New Drug and Commences Phase 1 Human Trials
6 December 2023
NMRA-266, a molecule with selective affinity for enhancing the activity of the M4 muscarinic receptor, is being advanced by Neumora as a potential therapeutic option for the management of schizophrenia as well as various additional mental health conditions.
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If the protocol changes during the clinical trial, what do the subjects need to do?
Knowledge Base
2 min read
If the protocol changes during the clinical trial, what do the subjects need to do?
6 December 2023
The subjects should be informed about any changes in the protocol and asked for their consent before proceeding with the new procedures.
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Exploring RBN-2397's R&D successes and its clinical results at the 2023 AACR
Exploring RBN-2397's R&D successes and its clinical results at the 2023 AACR
6 December 2023
On 14 Apr 2023, the first-in-class first-in-human phase 1 trial and translational study of the mono (ADP-ribose) polymerase-7 (PARP7) inhibitor RBN-2397 was reported at the AACR Congress.
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What are the advantages of eCRF over CRF?
"What" Series
2 min read
What are the advantages of eCRF over CRF?
6 December 2023
The advantages of eCRF over CRF include:Digital format,Security,Transportation,Ease of use,Flexibility.
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