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Administration Of Drug Product Applications In Usa
12 applications found
Clinical trials are scientific studies, conducted by doctors, to determine how well a new treatment works and if it has any side e?ects in people. The goal is to help people by finding better ways to prevent, screen for, diagnose, or treat disease. People can participate in clinical trials as patients or healthy ...
ByZymeworks Inc based in Vancouver, BRITISH COLUMBIA (CANADA)
This information is submitted to regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and Health Canada, to enable approval for patient use. ...
ByZymeworks Inc based in Vancouver, BRITISH COLUMBIA (CANADA)
One of the biggest challenges in clinical trials is recruiting volunteers. Often, the challenge lies in the ability to educate patients. Understanding the potential benefits and risks of participating in a clinical trial can be overwhelming. As a healthcare provider, you can help patients navigate the pros and cons and the questions they may have about clinical trials. With your help, patients can better decide what is the best course for their individual ...
ByCellphire Therapeutics, Inc. based in Rockville, MARYLAND (USA)
Since its inception, Yukon Medical has worked directly with clinicians and users to understand their needs and build products that keep them safe and address the complex challenges associated with current devices. The feedback and input of healthcare workers continues to be at the center of everything we do to inform our iterative, human-centered design process, resulting in products built with clinician needs and patient well-being in ...
ByYukon Medical, LLC based in Durham,, NORTH CAROLINA (USA)
The pinnacle of scientific evidence is the Level I study. i-FACTOR Bone Graft is one of a small group of bone grafting technologies that is supported by Level I evidence. i-FACTOR Bone Graft was evaluated in a 319-patient, prospective, randomized, controlled, multi-center clinical trial assessing its safety and efficacy compared to standard-of-care (autograft). Patients underwent anterior cervical discectomy and fusion (ACDF) and received either i-FACTOR Bone Graft or local autograft in a cortical allograft ring ...
ByCerapedics, Inc. based in Westminster, COLORADO (USA)
Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI), and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. ...
ByFinch Therapeutics Group, Inc. based in Somerville, MASSACHUSETTS (USA)
GI Dynamics has taken all necessary COVID-19 precautions to ensure patient safety, which remains top priority. Patient screening for the STEP-1 pivotal trial of EndoBarrier has reopened at select sites and enrollment will be conducted according to site requirements and CDC/FDA ...
ByGI Dynamics, Inc. based in Boston, MASSACHUSETTS (USA)
When it comes to pharmaceutical, nutraceutical, and chemical manufacturing, there is not only a high degree of regulation on the process, but an industry responsibility to supply the purest products for consumption and wear. At Filter Sciences, we create high-quality bag filter housings that exceed industry standards so that you can manufacture the best ...
ByFilter Sciences based in Fort Wayne, ALABAMA (USA)
Microbe Inotech Laboratories, Inc. provides a microbial genomics platform through licensed database agreements focused on the characterization of microorganisms, pathogens and anti-microbial resistance for pathogen detection, food safety inspections and issues, pharmaceutical discovery, public health surveillance, water and wastewater analysis, agriculture and microbiome analysis and comparisons. From a post-sequencingmetagenomic sample (i.e. DNA extracted from your sample) the MiL Inc. provides identification ...
ByPluton Biosciences, Inc. based in St. Louis, MISSOURI (USA)
From reusable and implantable medical devices to medical tubing, textiles and beyond, Sciessent’s antimicrobial technology can help protect against bacteria growth. ...
BySciessent LLC based in Beverly, MASSACHUSETTS (USA)
The pharmaceutical industry is one of the most regulated industries. Contaminants in drug products are examined throughout the manufacturing process, since their presence affects drug stability, behaviour and toxicity. Therefore, regulatory bodies such as the European Medicines Agency (EMEA) and the American Food and Drug Administration (FDA) strictly enforce continuous and ongoing analysis of organic or inorganic impurities from raw materials, ...
ByXenemetrix Ltd. based in Migdal Haemek, ISRAEL
On-line Monitoring of Bioprocesses. PTR-MS systems can be used to gather highly relevant process related information in biopharmaceutical fermentations from analyzing volatile metabolites in the fermenters ...
ByIonicon Analytik Ges.m.b.H. based in Innsbruck, AUSTRIA