FDA CBER Updates
The latest guidances, approvals, and safety alerts from FDA CBER, curated by automated regulatory intelligence.
Provides recommendations to support consistent, controlled blood collection, processing, and storage when manufacturing blood components using the buffy coat…
Clarifies FDA expectations for potency assessment strategies for active immunotherapy products, which may influence how sponsors design potency assays and…
Clarifies FDA CBER’s expectations for developing potential cellular and gene therapy products, emphasizing coordinated planning across manufacturing (CMC)…
Provides FDA CBER recommendations for evaluating blood donor eligibility and deferring potentially exposed donors in response to Ebola virus, along with…
Discusses how FDA may consider and leverage prior knowledge when developing human gene therapy products that incorporate genome editing, potentially…
Clarifies expectations for submitting continuous glucose monitoring (CGM) data from clinical trials to support review of endpoints and analyses in FDA…
Introduces Chemistry, Manufacturing, and Controls (CMC) flexibility approaches for developing human cellular and gene therapy products intended to support a…
Topic: Status: Draft.
Topic: Status: Draft.
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval; Draft Guidance for Industry…
Clarifies the processes for bioresearch monitoring inspections to ensure compliance with FDA regulations, emphasizing the importance of adherence to Good…
Outlines comprehensive recommendations for the inclusion and reporting of QTc information in labeling for human prescription drugs and biological products to…
Clarifies submission pathways for cross-center master files across various FDA centers, enhancing inter-center communication and efficiency.
FDA releases draft guidance on CMC requirements for gene therapy products, addressing manufacturing complexity and quality control.
Topic: Status: Draft.
Topic: Status: Draft.
Clarifies and proposes how FDA CBER intends to apply expedited development and review programs to regenerative medicine therapies intended for serious…
Withdrawn FDA CBER guidances for biologics indicate that certain previously published regulatory recommendations may no longer be relied upon for current…
Recommends how blood establishments and testing developers should test donated blood for Hepatitis B surface antigen (HBsAg) to strengthen transfusion safety.
Topic: Status: Draft.