FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Conduct-of-Clinical Trial-During-COVID-19-QA Updated 05.14.20.pdf
Test Guidelines for Pesticide Data Requirements | US EPA
In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product.
Guidance for Identifying, Selecting and Evaluating Open Literature Studies | US EPA
This guidance for Office of Pesticide Program staff will assist in their evaluation of open literature studies of pesticides. It also describes how we identify, select, and ensure that data we use in risk assessments is of sufficient scientific quality.
69404 Federal Register {1998} ~[OIRA meeting?} Whitehouse.gov
*****!!!!*****{includes discussion of establishment of cPAD and other human safety levels} "MRDlG of 0.3 mg/l for chlorine dioxide. The proposed MRDlG was based on a RID of 3 ... health risk for chlorite and chlorine dioxide considering the new CMA study (EPA, ... Carcinogen Risk Assessment (EPA, based on a ..."
Conducting a Human Health Risk Assessment | Risk Assessment | US EPA
"RfD is generally expressed mg/kg/day. RfD = NOAEL (or LOAEL or BMDL) / UFs" "(RfC), is used to assess inhalation risks for mg/m3" "This page provides the step-by-step instructions to how the EPA conducts a human health risk assessment with additional links to models, tools, databases and related products." "When there are alternative procedures having significant biological support, the Agency encourages assessments to be performed using these alternative procedures, if feasible, in order to shed light on the uncertainties in the assessment"
Trump’s EPA team overrules career scientists on toxic chemical - POLITICO
2020. Changes to the EPA safety assessment processes to include political review of proposed limits for human safety, rather than just review by scientists.
Test Guidelines for Pesticides and Toxic Substances | US EPA
Documents that specify methods EPA recommends to generate data submitted to EPA to support the registration of a pesticide, setting of a tolerance or tolerance exemption for pesticide residues, or the decision making process for an industrial chemical.
Federal Register :: Draft Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis ***Request for Comment
2020. EPA is announcing the availability of and seeking public comment on a draft guidance document
Biocompatibility Testing of Medical Devices – Standards Specific Information for the **Accreditation Scheme** for Conformity Assessment (ASCA) Pilot Program ~FDA
Sept 2020. Lab and test standards and requirements.
Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies
"Historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies."
ToxRTool - Toxicological data reliability assessment tool | EU Science Hub
The software-based tool “ToxRTool” (Toxicological data Reliability Assessment Tool) provides comprehensive criteria and guidance for evaluations of the inherent quality of toxicological data, thus making the decision process of assigning reliability categories more transparent and harmonised. ToxRTool consists of two parts, one to evaluate in vivo and one to evaluate in vitro data.The primary result of the tool is the assignment of Klimisch categories 1, 2 or 3 (Klimisch et al., 1997). Additionally, the tool offers the option to assign a Klimisch category according to personal judgement.
The ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) are a checklist of information to include in publications describing animal research.
What is repeated dose toxicity (definition, NOAEL, subacute, subchronic, chronic toxicity), study design and how it is used for hazard classification and risk assessment.
Immune, Dermal and Infectious Diseases Program ~NIOSH, CDC
The mission of the NIOSH research program for Immune, Dermal & Infectious Diseases is to eliminate occupational injuries, illnesses, and fatalities among workers in these industries through a focused program of research and prevention. Primary efforts are focused on hazard identification since when potential hazards are recognized, work-related dermal and immune diseases can often be prevented or their effects minimized. Research to better understand the impact of occupational exposures to chemical, biological, or infectious agents.
The Model Averaging for Dichotomous Response Benchmark Dose (MADr-BMD) Tool ~EPA, NIOSH
{Related to Predictive Models and Tools for Assessing Chemicals under the Toxic Substances Control Act (TSCA)} Providing quantal response models, which are also used in the U.S. EPA benchmark dose software suite, and generates a model-averaged dose response model to generate benchmark dose and benchmark dose lower bound estimates.