Sentences with phrase «human drug application»

The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505 (b)(1) or section 351 (a) of the Public Health Service Act for which the priority review voucher is used.

The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2).

Not exact matches

The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 505 (b)(1) or section 351 (a) of the Public Health Service Act will be submitted after the date of the approval of the material threat medical countermeasure application.

He has submitted his first clinical - trial application to the US Food and Drug Administration, and hopes to begin testing the rice - derived HSA in humans within the next two years.

In the United States, such clinical trials are effectively banned by a rule that prevents the Food and Drug Administration from reviewing applications for any procedure that would introduce heritable changes in human embryos.

The principle component of the new panel, hydrogel — a polymer network filled with water — is safe to use in and on the human body, having already found use in applications ranging from drug delivery to creating scaffolds for tissue engineering and wound healing.

Because of the legislation, a FDA spokesperson noted in an email, «the agency will not receive or review INDs [Investigational New Drug applications] for human subject research utilizing genetic modification of embryos for the prevention of transmission of mitochondrial disease in FY 2016 and human subject research using these technologies can not be conducted in compliance with the Federal Food, Drug, and Cosmetic Act and FDA's implementing regulations.»

Exploiting the same pre-clinical model used for their studies, the researchers are testing the efficacy of this kind of drug candidates against cancer stem cells, and the possibility of identifying combination regimens with standard chemotherapies with minimized toxic effects, with the perspective of their possible application for the treatment of human breast cancer.

Moreover, Plemper adds, his team believes this drug could have additional applications in veterinary medicine to treat other morbilliviruses in animals other than humans.

He will assemble a group of people to voluntarily try an existing drug for a new application before a pharmaceutical company embarks on a bigger, more costly human trial.

This means that these devices have the potential to be used in the human body in the future in applications such as drug delivery and locating cancer cells.

For eventual human application, lowest doses of a drug are always desirable but this must be balanced with efficacy of the compound.

Thus, neural derivatives of disease - specific human pluripotent stem cells constitute a relevant biological resource for exploring the impact of adult - onset HD mutations of the HTT gene on the division of neural progenitors, with potential applications in HD drug discovery targeting HTT - dynein - p150Glued complex interactions.

Our Human Emulation System sets a new standard for recreating true - to - life human biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, chemical - based consumer products, and personalized heHuman Emulation System sets a new standard for recreating true - to - life human biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, chemical - based consumer products, and personalized hehuman biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, chemical - based consumer products, and personalized health.

Phenylalanine pairs capable of forming a molecular switch are also present in many other signaling proteins, including receptors in human cells, making it an attractive target for drug design and biotechnology applications.

Human embryonic stem cellsImage: Wikimedia commons, Nissim Benvenistylinkurl: Advanced Cell Technology; http://www.advancedcell.com/ (ACT) filed an Investigational New Drug (IND) application yesterday (November 18) to conduct a phase I / II trial using hESCs to treat a genetic eye disease.

Farokhzad and colleagues have considerable expertise with bench - to - bedside translation of nanotechnologies for medical applications, and foundational work done in part by his team has led to the development and first in human testing of a targeted nanoparticle capable of controlling drug release for treatment of cancers, and the first in human testing of a targeted nanoparticle vaccine capable of orchestrating an immune response to facilitate smoking cessation and relapse prevention.

Our Human Emulation System ™ sets a new standard for re-creating true - to - life human biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, food, and chemical - based consumer prodHuman Emulation System ™ sets a new standard for re-creating true - to - life human biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, food, and chemical - based consumer prodhuman biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, food, and chemical - based consumer products.

This postdoctoral fellow is expected to develop and lead an interdisciplinary research project aimed at creating microengineered human «organ - on - chip» models and exploring their use for drug discovery applications.

Translational medicine is the integrated application of innovative pharmacology tools, biomarkers, clinical methods, clinical technologies and study designs to improve disease understanding, confidence in human drug targets and increase confidence in drug candidates, understand the therapeutic index in humans, enhance cost - effective decision making in exploratory development and increase phase II success.

Additionally, the head of a prominent human embryonic stem cells firm (Geron) has publicly questioned the viability of commercialized therapeutic applications of autologous hiPSCs due to the regulatory requirements imposed by the US Food and Drug Administration [7].

Her research achievements helped advance the development and application of human relevant in vitro models for drug discovery.

Our Human Emulation System sets a new standard for recreating true - to - life human biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, food, and chemical - based consumer prodHuman Emulation System sets a new standard for recreating true - to - life human biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, food, and chemical - based consumer prodhuman biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, food, and chemical - based consumer products.

These two properties (self - renewal and pluripotency) confers human pluripotent stem cells a unique interest for clinical applications since they could allow the production of infinite quantities of cells for disease modelling, drug screening and cell based therapy.

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The test kits are also used for human forensic toxicology drug screening applications.

Such applications for human consumption are confounding [McCaffrey's word] our Federal drug control testing programs, if they contain THC, and are of significant concern.»

An instance of a regulatory body — and a court — grappling with the human rights implications that arise from drug addictions of registrant was illustrated in Wright v. College and Association of Registered Nurses of Alberta, 2012 ABCA 267 (September 18, 2012)[application for leave to appeal to the SCC filed Nov 16, 2012].

The Divisional Court has dismissed a judicial review application of an arbitration decision that held that pre-access drug and alcohol testing was contrary to the parties» collective agreement and the Ontario Human Rights Code.

Tags for this Online Resume: HR, Human Resources, Recruiter, Applications, Benefits, Drug Screen, Employee Relations, Forth Programing Language, HR Metrics, Human Resources Information System

Human Resources Generalist 2008 — 2008 Successfully managed the staffing process for Cincinnati (PEP) business unit, including processing employment applications, interviewing, drug testing, background checks and reference checks.