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We propose this 2-week timeframe to prevent required material from being inadvertently misplaced, lost, or destroyed over the long term. We
propose to expand the scope of FDA-regulated nonclinical laboratory studies to specifically include toxicity studies. This is a mnemonic that
signifies quality data to stakeholders that conduct clinical and nonclinical studies. We intend these periodic reports to give a general overview of the
study. Any protocol requiring only those tests, with their approved parameters, would not require additional review before study initiation. A
description of these provisions is given in the Description section of this document with an estimate of the annual reporting and recordkeeping
burden. Our proposal replaces these scientists or other professionals with the term contributing scientist. This proposed change will include the
applications and submissions to FDA listed in the definitions section of this proposal. We propose these changes consistent with our proposal
revising the testing facility definition and our goal of applying the GLP regulations to all nonclinical laboratory studies, including multisite studies. The
Food and Drug Administration FDA is proposing to amend the regulations for good laboratory practice GLP for nonclinical laboratory studies to
require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to
support applications or submissions for products regulated by FDA. Therefore, we propose this action to help protect the safety and welfare of
animal research subjects involved in FDA-regulated nonclinical laboratory studies and clinical investigations, and to help ensure the reliability and
integrity of the data submitted to FDA to support FDA decisions concerning new animal drugs. A testing facility may contract with commercial
archives to provide a repository for all material to be retained. This must include training and experience with GLP requirements. Under the
proposed amendment to part , a clinical investigator disqualified under part also would be ineligible to conduct any nonclinical laboratory study
intended to support an application for a research or marketing permit for a new animal drug. The term does not include studies involving human
subjects, clinical studies, or clinical investigational use in animals. We propose this change because, in a multisite study, the testing facility might not
be the person treating the test system with the test article as specified in the current definition. Since the pre-specified, periodic timing of process-
based inspections can result in the lack of an inspection of a short-term study, this definition is necessary to address our proposed addition of
process-based inspections see also the discussion of the definition of process-based inspection in section III. This proposed rule would not result
in an expenditure in any year that meets or exceeds this amount. For example, a single-site study conducted in a facility situated on a large campus
with multiple buildings might have one or more principal investigators. Results of nonclinical laboratory studies may be used by firms in support of
applications and submissions to FDA, including applications and submissions for research and marketing of new products. These proposed
changes will clarify and update the regulations. We propose principal investigator responsibilities consistent with a principal investigator's role of
ensuring compliance with part 58 for a specific phase. This proposed rule would amend the regulations regarding GLPs and would require that
nonclinical laboratory studies sometimes referred to as preclinical studies follow a complete quality system approach, referred to as a GLP Quality
System, when safety and toxicity studies support or are intended to support applications and submissions to FDA. All submissions received must
include the Docket No. We propose this addition to help ensure that all untoward health-related observations of test animals are captured and
reported so that FDA reviewers can consider their possible effect on study results. Revise the heading of subpart F to read as follows:. The term
does not include basic exploratory studies carried out to determine whether a test article has any potential utility or basic exploratory studies to
determine the physical or chemical characteristics of a test article. For more information please see the Document Drafting Handbook sections on
the use of Supplementary Information in Federal Register documents. Testing facility means the person responsible for coordinating, conducting, or
completing a nonclinical laboratory study, or any combination thereof. These animals may be treated for disease or signs of disease as deemed
necessary by the study's attending veterinarian. We believe that this proposed rule is not a significant regulatory action as defined by Executive
Order Finally, the proposed rule would incorporate wording consistent with some of the existing domestic and international guidelines, rules or
regulations covering good laboratory practices such as those established by the OECD. Under existing regulations that require providing the final
study report and any Start Printed Page amendments, we expect that both original and amended versions of reports from all contributing scientists
be appended to the final study report. Therefore, neither an environmental assessment nor an environmental impact statement is required. FDA is
proposing to amend the GLP regulations in part 58 to require the use of a complete quality system approach, referred to as a GLP Quality System,
for the conduct of nonclinical laboratory studies when safety or toxicity studies, or both, support or are intended to support applications or
submissions to FDA. These studies are intended to generate data that are essential for the approval or licensure of products intended for human
use. The comments also requested that we not be as prescriptive as those OECD directives. Personnel who work with animals must have both
general and species-specific training and experience.