CBER definition
Examples of CBER in a sentence
By way of this notice, ▇▇▇▇▇▇ ▇▇ hereby grants __________________ a right of reference to the data contained within Biologics License 2.55, STN 103231, CBER Reference Numbers: 87-0508 and 87-0509.
Both parties shall maintain standards of performance in accordance with the applicable recommendations of the Center for Biologics Evaluation and Research (CBER) of the FDA, the applicable requirements of all applicable state regulatory agencies, and to comply with all other applicable laws, rules, and regulations.
With respect to any Initial Blood Screening Assay or Future Blood Screening Assay, the objective of the parties is to share equally the aggregate cost of maintaining safety stocks of raw components, work-in-progress, and finished as required by CBER.
The PK/PD analyses and exposure response modeling will be described in a separate SAP and report and will generally follow the guidance provided by FDA (Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), April 2003).
We had an Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) meeting on May 15, 2020 with the FDA in which discussed our overall development plan and our proposal to omit animal toxicity testing in light of the proven safety profile of MVA as a vaccine platform.
Rockville, Maryland 20852-1448 RE: Right of Reference to Tisseel® VH Kit Biologics License Application Submission Tracking Number (STN) 103231, CBER Reference Numbers: 87-0508 and 87-0509 [please revise to suite use of Tisseel] Dear ____________________, ▇▇▇▇▇▇ Healthcare Corporation, through ▇▇▇▇▇▇ ▇▇ (previously Immuno AG), a joint stock company duly organized and existing under the laws of Austria, is the owner of STN 103231 for the fibrin sealant, trade name Tisseel® VH Kit.
Complete weekly, monthly and an annual reports on activities, individuals served and costs of operation.
Patheon shall notify Cangene of any quality related inspections of the Manufacturing process of the Products by Regulatory Authorities, particularly CBER.
If at any time during the life of the contract, the Offeror fails to comply with cGMP in the manufacturing, processing and packaging of this therapeutic product and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product (a material failure) as identified by CBER and CDER, the Offeror shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure.
Clinical studies shall not begin until the responsible FDA Center (Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Review (CBER)) accepts the plans and protocols.