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.
Sample 1Sample 2Sample 3
CDER means FDA's Center for Drugs Evaluation and Research.
Sample 1Sample 2
CDER means Center for Drug Evaluation and Research.
Sample 1

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.

  • For resubmissions, 505(b)(2) applications must be cleared before the action, but it is not necessary to resubmit the draft 505(b)(2) Assessment to CDER OND IO unless the Assessment has been substantively revised (e.g., new listed drug, patent certification revised).

  • U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).

  • The CDER and ESR currency percentages were weighted based on the RC’s Status 1 and Status 2 caseloads to arrive at a composite score.

  • 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.

  • Progressive Economy Forum, June 2022£15 an hour is a target that must be recognised and addressed by the local government employers.

  • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER).

  • 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.

  • Skip to signature block.* Note for CDER: SE5, SE6, and SE7 submissions may also trigger PREA.Q3: Does this indication have orphan designation?Yes.


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 plan created by the department and approved by the state transportation commission or a plan created by a local road agency and approved by the local road agency's governing body that includes provisions for asset inventory, performance goals, risk of failure analysis, anticipated revenues and expenses, performance outcomes, and coordination with other infrastructure owners.

  • Pest Management Plan and “PMP” means the Recipient’s plan dated March 9, 2010, which: (i) addresses the concerns relating to the Project risks associated with potential increases in the use of pesticides for agricultural production, intensification and diversification and controlling disease vector populations arising from irrigation schemes; (ii) sets forth mitigation and monitoring measures to be taken during Project implementation and operation to eliminate adverse environmental and social impacts, offset them, or reduce them to acceptable levels; (iii) recommends institutional measures to strengthen national capacities to implement the mitigation and monitoring measures; and (iv) as part of the implementation arrangements, identifies national agencies and other partners that could play a vital role in the success of the Project.

  • 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.

  • CDE means any domestic corporation or partnership, for Federal tax purposes, certified as a CDE by the CDFI Fund pursuant to IRC § 45D(c).

  • 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.

  • Hospital clinic means an outpatient care clinic operated and affiliated with a hospital and under the direct authority of the hospital’s P&T committee.

  • 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/sp.

  • Project Management Plan means the management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;

  • 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 means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

  • 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: