scholarly journals Assessment of Dependence Liability of New Molecular Entities under the Current FDA Draft Guidance Document: Seeking Best Practices

2016 ◽  
Vol 05 (01) ◽  
Author(s):  
David VG ◽  
Zachary JZ
Keyword(s):  
Best Practices ◽  
Guidance Document ◽  
Draft Guidance ◽  
Dependence Liability

Critical issues in dependence liability testing under the FDA draft guidance document

2014 ◽  
Vol 70 (3) ◽  
pp. 311
Author(s):  
David Gauvin ◽  
Jill Dalton ◽  
Margaret McComb ◽  
Robert Code ◽  
Michael Eliel ◽  
...  
Keyword(s):  
Guidance Document ◽  
Draft Guidance ◽  
Critical Issues ◽  
Dependence Liability

Naturally Occurring Asbestos Assessment, Exposure Prevention Strategies During Construction, and Capping for Long-Term Protection: a California, USA Example

2020 ◽  
Author(s):  
Sarah Kalika
Keyword(s):  
School Improvement ◽  
Best Practices ◽  
Residential Buildings ◽  
The United States ◽  
Guidance Document ◽  
School Construction ◽  
Improvement Project ◽  
Naturally Occurring ◽  
Naturally Occurring Asbestos ◽  
Sampling Procedures

<p>The government of California, in the United States, has created requirements that are intended to protect the public from naturally occurring asbestos (NOA), partly due to the widespread areas in which asbestos minerals (including chrysotile and various amphiboles) are found within the state.Over ten years ago, the California Department of Toxic Substances Control Schools Unit published a thorough set of guidelines for addressing NOA at school construction sites.Their guidance document includes soil sampling procedures and frequency, recommended laboratory analytical testing methods, construction best practices to protect nearby residents from airborne exposures, capping methods to prevent re-exposure to students and public following the completion of the school improvement project, and follow-up procedures to ensure the capping method remains protective.Many of these best practices have been adapted into the construction process for commercial and residential buildings.<span>  </span>In California, protection of air is the regulated by Air Quality Management Districts, who regulate the generation of airborne asbestos as an air pollutant.Additionally, workers who are employed by a company, and working at a job site where asbestos is present, are protected by California Occupational Safety and Health (Cal-OSHA). Cal-OSHA requires varying protective measures to be implemented, based on the amount of asbestos that the worker is exposed to during their time at the construction project.This presentation will review the various regulations and best practices used in California by comparing a school construction project with a commercial office building. </p>

scholarly journals Update to U.S. National Response Team's Abandoned Vessels Authorities and Best Practices Guidance

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
Rebecca J. Brooks
Keyword(s):  
Best Practices ◽  
Relevant Information ◽  
Major Elements ◽  
Third Party ◽  
Guidance Document ◽  
Long Term Storage ◽  
National Response ◽  
Response Team ◽  
Additional Section

Abstract The U.S. National Response Team promulgated an interagency guidance document entitled “Abandoned Vessel Authorities and Best Practices Guidance” (AVG) in 2014 to address a myriad of questions that the Federal On-Scene Coordinators and broader response community tend to face when mitigating threats caused by abandoned or derelict vessels. This document compiles information surrounding existing laws, policies, and best practices to inform and advise responders without bogging them down in “legalese” or forcing them to search from document to document to find all the relevant information. In the aftermath of the 2017 Atlantic Hurricane Season and associated responses, the National Response Team tasked its Preparedness Committee to reopen the 2014 AVG to ensure the document addressed the challenges that were brought to light amid the responses. The Committee chartered a working group to systematically review and update this document and incorporate the latest pertinent policy changes, including those from Federal Emergency Management Agency to ensure that it most thoroughly addressed the gamut of issues a responder may come up against in the arena of abandoned (or derelict, or displaced) vessel management. The updated AVG was completed and approved by the NRT in 2020 and is posted to the NRT website. Major updates include: Considerations for long-term storage and disposal;Clarification on foreign-flagged vessel nuances;Information for responders to consider regarding contaminants other than those covered under NCP/ESF constructs (e.g. if typical response authorities do not cover a scenario, what options might the responder still leverage);An additional section addressing nuances of managing multiple vessel casualties at once, either due to a natural disaster or an act or omission from a third party; andImportant differences between National Contingency Plan and Stafford Act funded/organized responses. This paper dives into the rationale for making changes, the benefits of additions made, the processes and methodologies for undertaking updates, and major elements of the AVG to provide a snapshot of the guidance it affords the reader.

PP216 Indirect Treatment Comparison Assessment: An Improvement Intervention In The Scottish Medicines Consortium

2021 ◽  
Vol 37 (S1) ◽  
pp. 27-28
Author(s):  
John Scott ◽  
Moira McMurray ◽  
Rickie O'Connell ◽  
Pauline McGuire ◽  
Noreen Downes
Keyword(s):  
Focus Group ◽  
Small Sample Size ◽  
Small Sample ◽  
Guidance Document ◽  
Draft Guidance ◽  
Treatment Comparison ◽  
Direct Head ◽  
Indirect Treatment ◽  
The Impact

IntroductionThe Scottish Medicines Consortium (SMC) conducts early health technology assessment (HTA) of new medicines on behalf of the National Health Service Scotland based on pharmaceutical company submissions. As the appraisals are conducted close to the point of marketing authorization, there is often a lack of direct head-to-head data. In 2019, assessment of relevant comparative efficacy was informed via indirect treatment comparisons (ITC) in 55 percent (36/66) of submissions. While the ITCs are essential to the decision-making process, they are frequently incomplete.MethodsA focus group was conducted with the clinical assessment team (n = 11) to explore problems in the submission process and to identify areas for improvement. It was agreed that providing improved guidance to companies prior to submission may prevent future inconsistencies. A working group (n = 5) was tasked with identifying and implementing potential solutions. The group reviewed the focus group findings, relevant literature, and guidance from other organizations. Draft guidance was developed that was reviewed by two pharmaceutical industry representatives (SMC subcommittee members).ResultsFindings from the focus group highlighted issues broadly related to the incomplete presentation and reporting of ITCs. The improved guidance document outlined specific requirements in a checklist format for reporting and presenting the results of different ITC data. This guidance was published in February 2020. To evaluate the impact of the updated guidance and to identify any further changes required, a follow-up focus group and survey of industry representatives is planned for March 2021.ConclusionsThe aim of the ITC guidance is to provide pharmaceutical companies with direction to improve the quality and transparency of reporting, which will in turn improve the quality of HTAs and thus strengthen the recommendations provided by the SMC. The follow-up focus groups and survey will assess the impact of the guidance. It is acknowledged that the results of this process may be limited by the small sample size and short duration of the assessment.

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