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.
CDER means FDA's Center for Drugs Evaluation and Research.
CDER means Center for Drug Evaluation and Research.

Examples of CDER in a sentence

  • SUBMISSION FORMAT REQUIREMENTS The Electronic Common Technical Document (eCTD) is CDER and CBER’s standard format for electronic regulatory submissions.

  • The dataset that is requested in Item III below is for use in a clinical site selection model that is being piloted in CDER.

  • Electronic Drug Registration and Listing System (eDRLS) databaseThe electronic Drug Registration and Listing System (eDRLS) was established to supports the FDA’s Center for Drug Evaluation and Research (CDER) goal to establish a common Structured Product Labeling (SPL) repository for all facilities that manufacture regulated drugs.

  • CDER has produced a web page that provides specifications for sponsors regarding implementation and submission of clinical and nonclinical study data in a standardized format.

  • Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.

  • This Guide integrates and updates information discussed previously in the Study Data Specifications and the CDER Common Data Standards Issues documents.

  • The level of care (LOC) criteria are based on California Code of Regulations (CCR) Title 22 §§ 51343, 51343.1 and 51343.2 which specify the LOC requirements for admittance to an intermediate care facility for the developmentally disabled (ICF/DD), ICF/DD-H (habilitative) or ICF/DD-N (nursing.) The Client Development Evaluation Report (CDER) is utilized in making LOC determinations.

  • As noted above, this Guide supersedes all previous Study Data Specifications documents (Versions1.0 - 2.0) and CDER Study Data Common Issues Documents (Versions 1.0 -1.1).

  • In connection with that petition, both GSK and plaintiffs met with representatives from the FDA CDER to discuss their views of the studies and their impact on Zofran’s label.

  • CDER seeks to significantly enhance review efficiency and review quality by providing the staff with a better understanding of the pharmaceutical industry and its operations.


More Definitions of CDER

Related to CDER

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • veterinary clinic means a building where animals are given medication or surgical treatment and are cared for during the time of such treatment for financial gain;

  • Asset Management Plan means a strategic document that states how a group of assets are to be managed over a period of time. The plan describes the characteristics and condition of infrastructure assets, the levels of service expected from them, planned actions to ensure the assets are providing the expected level of service, and financing strategies to implement the planned actions. The plan may use any appropriate format, as long as it includes the information and analysis required to be in a plan as described in Ontario’s Building Together: Guide for Asset Management Plans.

  • veterinary surgeon means a veterinary surgeon within the meaning of the Veterinary Surgeons Act 1936.

  • Forest management plan means a written plan prepared and signed by a qualified forester that prescribes measures to optimize production, utilization, regeneration, and harvest of timber. The forest management plan shall include a schedule and timetables for the various silvicultural practices used on forestlands, which shall be a maximum of 20 years in length. A forest management plan shall include all of the following:

  • Nutrient management plan means a plan developed or approved by the Department of Conservation and Recreation that requires proper storage, treatment and management of poultry waste, including dry litter, and limits accumulation of excess nutrients in soils and leaching or discharge of nutrients into state waters.

  • Emergency medical care provider means an individual who has been trained to provide emergency and nonemergency medical care at the first responder, EMT-basic, EMT-intermediate, EMT-paramedic, paramedic specialist or other certification levels recognized by the department before 1984 and who has been issued a certificate by the department.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • Pharmaceutical care means the provision of drug therapy and

  • Asset Management Company/UTI AMC/AMC/Investment Manager means the UTI Asset Management Company Limited incorporated under the Companies Act, 1956, (1 of 1956) [replaced by The Companies Act, 2013 (No.18 of 2013)] and approved as such by Securities and Exchange Board of India (SEBI) under sub-regulation (2) of Regulation 21 to act as the Investment Manager to the schemes of UTI Mutual Fund.

  • ESBD means the Electronic State Business Daily, the electronic marketplace where State of Texas bid opportunities over $25,000 are posted. The ESBD may currently be accessed at http://www.txsmartbuy.com/esbd.

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • Hospital pharmacy means a pharmacy providing pharmaceutical care to

  • Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Acute care hospital means a Hospital that provides Acute Care Services. Adjudicate means to deny or pay a Clean Claim. Administrative Services see MCO Administrative Services. Administrative Services Contractor see HHSC Administrative Services Contractor.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Medical history means information regarding any:

  • Asset Management Company/UTI AMC/AMC/Investment Manager means the UTI Asset Management Company Limited incorporated under the Companies Act, 1956, (1 of 1956) replaced by The Companies Act, 2013 (No. 18 of 2013) and approved as such by Securities and Exchange Board of India (SEBI) under sub-regulation (2) of Regulation 21 to act as the Investment Manager to the schemes of UTI Mutual Fund;

  • Education program means any program that is principally engaged in the provision of education, including, but not limited to, early childhood education, elementary and secondary education, postsecondary education, special education, job training, career and technical education, and adult education, and any program that is administered by an educational agency or institution.

  • Prescription monitoring program “PMP,” or “program” means the program established pursuant to 657—Chapter 37 for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.

  • Participating Hospice Care Program Provider means a Hospice Care Program Provider that either: (i) has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield to provide services to participants in this benefits program, or; (ii) a Hospice Care Program Provider which has been designated by a Blue Cross and/or Blue Shield Plan as a Participating Provider Option program.

  • Participating Clinical Professional Counselor means a Clinical Professional Counselor who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Psychiatric hospital means an Institution constituted, licensed, and operated as set forth in the laws that apply to Hospitals, which meets all of the following requirements:

  • Non-Participating Clinical Professional Counselor means a Clinical Professional Counselor who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • o GENERAL HOSPITAL means a hospital that is designed to care for medical and surgical patients with acute illness or injury.