Application for research or marketing

A period of at least 2 years following the date on which an application for research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drag Administration. 

In the United States, GLP regulations (21 CFR 58) apply to safety or animal toxicology studies performed during research and development. These regulations define GLPs for conducting non-clinical laboratory studies that support or are intended to support applications for research or marketing permits for products... 

To validate critical studies, such as long-term and reproduction toxicity studies, submitted to INDs or NDAs. These studies are selected at each center from master schedules collected in the course of previous GLP inspections or from reviews prepared by the pharmacologist responsible for evaluating applications for research and marketing permits. 

Sponsor 1) A person who initiates and supports, by provision of financial or other resources, a (nonclinical laboratory) study 2) a person who submits a (nonclinical laboratory) study to the EPA (FDA) in support of an application for a research or marketing permit or 3) a testing facility, if it both initiates and actually conducts the study. 

Test substance (EPA) A substance or mixture administered or added to a test system in a study, in which the substance or mixture 1) is the subject, or contemplated subject, of an application for a research or marketing permit, or 2) is an ingredient or product of a substance as defined above. 

The EPA regulations include a statement of compliance or noncompliance ( 160.12) and a statement indicating the effects of noncompliance ( 160.17), while the FDA regulations address these issues in their Subpart K. The EPA statements say that any person who submits an application for a research or marketing permit shall submit a statement signed by the applicant, the sponsor, and the study director that the study was either conducted in accordance with GLPs, conducted in part in accordance with GLPs (with... 

The basic mechanism of enforcement was to be inspection of testing facihties by FDA field investigators. The FDA s authority to conduct inspections of facilities engaged in interstate commerce of regulated products is well estabhshed, and such inspections are the primary method of enforcement of the FFDCA. Under the proposal, studies performed by a testing facility that refused to permit inspection would not be accepted in support of an application for a research or marketing permit. 

Disqualification is the most severe penalty that FDA can apply for failure to comply with GLP requirements. If a laboratory is disqualified, the completed or future studies conducted by that laboratory may not be accepted by FDA in support of an application for a research or marketing permit. It is even possible for prior FDA approval of a marketed product to be withdrawn if that approval was based in part on the study or studies conducted by a disqualified laboratory. 

A person who submits a study to the EPA in support of an application for a research or marketing permit or... 

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