scholarly journals Supplemental Regulatory Submission

2020 ◽  
Author(s):  
Keyword(s):  
Regulatory Submission

Design Research Strategies for a Total Artificial Heart

2017 ◽  
Vol 61 (1) ◽  
pp. 593-596
Author(s):  
L. Bryant Foster
Keyword(s):  
Participatory Design ◽  
Artificial Heart ◽  
Design Research ◽  
Total Artificial Heart ◽  
Research Strategies ◽  
Regulatory Requirements ◽  
Regulatory Constraints ◽  
Regulatory Submission ◽  
Conducting Research ◽  
Validation Testing

Human factors formative and validation testing have become a part of the regulatory submission process for new medical devices in the U.S. and Europe. However, there are additional design research methods that manufacturers should consider implementing before and during development to ensure their products are safe, usable and desirable. Many manufacturers avoid conducting design research due to regulatory requirements to document adverse events. This paper discusses contextual research and participatory design performed to gather user needs for a new Total Artificial Heart TAH-t) user interface as well as strategies for conducting research with current users to comply with regulatory constraints.

OP171 Does Parallel Regulatory-Health Technology Assessment Reviews Affect Time To Health Technology Assessment Decisions?

2018 ◽  
Vol 34 (S1) ◽  
pp. 62-63
Author(s):  
Jesmine Cai ◽  
Tina Wang ◽  
Neil McAuslane ◽  
Lawrence Liberti
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Review Process ◽  
Health Technology ◽  
Access To Medicines ◽  
Regulatory Approval ◽  
Regulatory Submission ◽  
Therapeutic Value ◽  
Assessment Decisions ◽  
Health Canada

Introduction:Timely recommendation by Health Technology Assessment (HTA) agencies for drug reimbursement is critical to ensure patient access to medicines of therapeutic value. In this study, HTA performance was examined in terms of their outcome and timing by looking at how 103 drugs, which gained regulatory approval from 2013 to 2015, were assessed by HTA agencies from 2014 to 2016.Methods:Products must have received regulatory approval from one of the following regulatory agencies: EMA (Europe), Health Canada (Canada) and TGA (Australia). The first HTA recommendations were then collected from PBAC (Australia), CADTH (Canada), HAS (France), IQWiG (Germany), SMC (Scotland) and TLV (Sweden). The HTA decisions were classified as positive, positive with restrictions, negative and multiple.Results:Eighty-four drugs were approved in Europe before Australia and Canada. Of the studied HTA agencies, PBAC had the highest percentage of products recommended within a year from regulatory approval (93 percent). In addition, Australia had the shortest median time between first regulatory submission by any of the three agencies and HTA recommendation (553 days) as compared to Europe (616 days) and Canada (722 days). This can be attributed to the TGA/PBAC parallel process. However, Australia has the highest proportion of products receiving a negative PBAC recommendation (62 percent).Conclusions:The majority of drugs were first submitted for reimbursement in Europe, but the time from regulatory submission to HTA decision was the fastest in Australia. This can be attributed to the TGA/PBAC parallel review process, which showed its benefit in reducing the overall time. A parallel review process is also available in Canada; however, it is not utilized as frequently by companies as in Australia.

scholarly journals Formulation Development Studies for Sterile Dosages: A Comprehensive Review

2021 ◽  
Vol 11 (3) ◽  
pp. 122-125
Author(s):  
Govind Raju. N ◽  
Shishir Ojha ◽  
Sumit Kumar Roy ◽  
Amit Kori ◽  
Anjaneyulu Vinukonda
Keyword(s):  
Hold Time ◽  
Compatibility Studies ◽  
Formulation Development ◽  
Comprehensive Review ◽  
Critical Quality Attributes ◽  
Pharmaceutical Development ◽  
Regulatory Submission ◽  
Special Studies ◽  
Route Of Delivery ◽  
Processing Aids

Sterile generic dosage development requires that specific critical quality attributes be considered and evaluated, regardless of the route of delivery or the type of registration application. The review briefed with an overview of Pharmaceutical Development study requirements. Each of the various stages of studies like Compatibility with the packaging materials, manufacturing vessels, processing aids, MOCs, Filters, Tubing’s and Gaskets also with special studies to be conducted as part of Regulatory Submission, process considerations. Thus, the chapter offers the formulator an overview of the foundational principles associated with formulation development /Pre-formulation studies of sterile products. Keywords: Pharmaceutical Development, Compatibility, Studies, Hold time.

scholarly journals Communicating Regulatory High Throughput Sequencing Data Using BioCompute Objects

2020 ◽  
Author(s):  
Charles Hadley S. King ◽  
Jonathon Keeney ◽  
Nuria Guimera ◽  
Souvik Das ◽  
Brian Fochtman ◽  
...  
Keyword(s):  
High Throughput Sequencing ◽  
Biological Data ◽  
Sequencing Data ◽  
Regulatory Submission ◽  
High Throughput Sequencing Data ◽  
Analysis Workflow ◽  
Regulatory Submissions ◽  
High Concordance ◽  
Next Generation Sequencing Ngs ◽  
Ngs Data

AbstractFor regulatory submissions of next generation sequencing (NGS) data it is vital for the analysis workflow to be robust, reproducible, and understandable. This project demonstrates that the use of the IEEE 2791-2020 Standard, (BioCompute objects [BCO]) enables complete and concise communication of NGS data analysis results. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data. Two separate, independent analyses were then carried out using BCOs as the tool for communication of analysis: one to simulate a pharmaceutical regulatory submission to the FDA, and another to simulate the FDA review. The two results were compared and tabulated for concordance analysis: of the 118 simulated patient samples generated, the final results of 117 (99.15%) were in agreement. This high concordance rate demonstrates the ability of a BCO, when a verification kit is included, to effectively capture and clearly communicate NGS analyses within regulatory submissions. BCO promotes transparency and induces reproducibility, thereby reinforcing trust in the regulatory submission process.

scholarly journals Bring Your Own Device (BYOD): A practical framework to leverage in the electronic patient-reported outcomes(ePRO) data collection in clinical trials

2021 ◽  
Author(s):  
Aman Thukral ◽  
Kelsey Linsmeier ◽  
Brooks Fowler ◽  
Sanjay Bhardwaj
Keyword(s):  
Clinical Trials ◽  
Health Status ◽  
Data Collection ◽  
Patient Reported Outcomes ◽  
Bring Your Own Device ◽  
Regulatory Submission ◽  
Patient Reported ◽  
Personal Devices

Patient-reported outcomes (PROs) are used in pharmaceuticaltrials to obtain trends in health status. Companies commonly provision tabletand smartphone devices to collect PRO information. Alternatively, the BringYour Own Device (BYOD) model allows patients to leverage personal devices andis actively being explored as a solution.  This article investigates thepotential benefits of BYOD and outlines a framework of considerations. Theframework addresses current challenges and proposes potential solutions toMeasurement Equivalence, Technical, and Operational concerns. BYOD has not yet beenimplemented on any studies for regulatory submission. Nonetheless, there isreason to believe the model will gain traction in the coming years. With theprovided framework, sponsors can assess whether the BYOD model is right for theconsidered study.

scholarly journals Demonstrating laboratory proficiency in bacterial mutagenicity assays for regulatory submission

2019 ◽  
Vol 848 ◽  
pp. 403075 ◽  
Author(s):  
Dan D. Levy ◽  
Atsushi Hakura ◽  
Rosalie K. Elespuru ◽  
Patricia A. Escobar ◽  
Masayuki Kato ◽  
...  
Keyword(s):  
Regulatory Submission

scholarly journals What Is “Preclinical Device Pathology”: An Introduction of the Unfamiliar

2019 ◽  
Vol 47 (3) ◽  
pp. 205-212 ◽  
Author(s):  
Nicole Kirchhof
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Background Information ◽  
Preclinical Studies ◽  
Test Animal ◽  
Medical Engineer ◽  
Preclinical Evaluation ◽  
Regulatory Submission ◽  
Ideal Position ◽  
Detailed Protocol

Medical device pathologists are involved in the preclinical evaluation of medical devices that will be temporarily inserted or permanently and often irreversibly implanted in the human body. The medical device industry is technology based, allowing for rapid device iterations; innovations occur at an accelerated rate compared to the innovations in the pharmaceutical industry. The device pathologist provides the pathology results and is, by training and experience, in an ideal position to help the medical engineer and innovator tackle biomedical problems and to comment on the possible and actual outcomes of preclinical studies. Device pathology expertise is typically a necessity in the prelude for regulatory submission. However, there is a lack of detailed guidelines for a comprehensive preclinical pathology evaluation of the final product after implantation in a test animal. What specifically unites device pathologists is the reliance on gross pathology as the basis for spatial context needed for appropriate histopathologic analyses, the knowledge of detailed protocol instructions, a good understanding of wound healing including the “implant trauma,” and interaction with ambitious device innovators. In this article, it is my aim to amalgamate the following articles in this issue with pertinent background information intended to be informative, critical, and stimulating.

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