CDER definition

CDER means the FDA’s Center for Drug Evaluation and Research or any successor thereto that is responsible for overseeing the NDA review and approval process.
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CDER means FDA's Center for Drugs Evaluation and Research.
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CDER means the Center for Drug Evaluation and Research of the United States Food and Drug Administration.
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Examples of CDER in a sentence

  • If TWC exercises its option to renew a grant, TWC may require that a separate financial closeout package be submitted through the CDER system no later than 11:59 p.m. Central Time on the 60th calendar day from the end of the grant period immediately preceding any such renewal, or another date specified by TWC.

  • Ambit shall provide the JCDC with monthly updates on: (i) the AC220 development program timeline; (ii) the status of the AC220-002 and AC220-003 Clinical Trials and any changes relevant to sample logistics from such trials; and (iii) feedback on interactions with CDER concerning requirements for the Companion Diagnostic.

  • The CDER should be updated every 3 years or whenever there is a significant change in the person's physical or mental capabilities.

  • SDRC also uses DDS form DS-1968 Vocational Services Referral Form along with collateral documents (IPP, Medical Evaluation, Psychological Evaluation, CDER, etc.) as part of the referral process.

  • Electronically submit a financial closeout package through TWC’s CDER system no later than 11:59 p.m. Central Time on the 60th day from the grant end date for the initial Grant Period specified in the Solicitation.

  • The monthly financial report in this requirement is a fillable online report that designated grantee personnel will complete by logging into TWC’s CDER system and keying monthly obligation, expenditure, program income, and, where applicable, match or leverage amounts for the Grant Award.

  • 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).

  • Metuchen agrees to perform in a timely manner all steps as may be required or as otherwise requested by VIVUS to effectuate VIVUS’ ability to engage in the VIVUS Exploitation Rights, including submitting an NDC Labeler code request SPL to FDA via ESG or CDER Direct Portal, indicating a new labeler and label addition (together, the “Labeler Addition”) and such other documentation as FDA, VIVUS and other third parties may require or request.

  • J&JPRD authorizes the CDER to use similar software as appropriate.

  • 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.


More Definitions of CDER

CDER means Center for Drug Evaluation and Research.
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Related to CDER

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