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Drug Master Files for CBER-Regulated Products
(Source: What's New at CBER)
Source: What's New at CBER - November 21, 2017 Category: Biomedical Science Source Type: news

Francis Crick Institute's £700m building 'too noisy to concentrate'
Some of the 1,250 people working at the year-old laboratory say its open plan layout, designed to produce collaboration, makes it hard to focus on workIt is a£700m cathedral to biomedical science, where scientists work together to make breakthroughs in cancer, neuroscience, pandemics and genetics. But the Francis Crick Institute is not proving to be the easiest place to concentrate.A year after opening, some of the 1,250 people working at the Crick Institute, in its central London laboratory, have complained that the open plan design, intended to assist informal collaboration, means some areas set aside for thinking ...
Source: Guardian Unlimited Science - November 21, 2017 Category: Science Authors: Robert Booth Tags: Science Architecture Medical research UK news Source Type: news

SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)- pdf
This is the CBER SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA). (Source: What's New at CBER)
Source: What's New at CBER - November 20, 2017 Category: Biomedical Science Source Type: news

Researchers identify hormone for treating sepsis
(University of California - Riverside) A research team led by a biomedical scientist at UC Riverside has discovered that the human protein resistin could be used to treat sepsis, the body's extreme and uncontrolled immune response to an infection. Without timely treatment, this medical emergency can rapidly damage tissue, leading to organ failure. The researchers found that mice expressing resistin had a 100 percent survival rate from a sepsis-like infection when compared to wild-type mice with the same infection. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - November 13, 2017 Category: Infectious Diseases Source Type: news

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Guidance for Industry and FDA Staff: IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b):  Questions and Answers Regarding the Scope of the Exception
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry
(Source: What's New at CBER)
Source: What's New at CBER - November 9, 2017 Category: Biomedical Science Source Type: news

Healing with hyperbaric oxygen therapy
Diving deep and flying high,?Mayo Clinic's Hyperbaric and Altitude Medicine program is approaching 10 years of service in Rochester, Minnesota. Although?hyperbaric oxygen therapy is rooted in medical science, the process still strikes some people as a bit of a mystery. "Many individuals have strong opinions as to what it is and what it isn?t," says [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - November 7, 2017 Category: Databases & Libraries Source Type: news

How I came to be the Biosleuth
To celebrate Medical Librarian’s Month we have invited medical librarians in our region to submit some information about who they are and the work that they do as medical librarians. Today we are concluding our series with a post from an independent medical librarian in Washington!  Julia Parker, The Biosleuth! Who am I? Julia Parker, M.S., M.L.I.S Where do I work? Biosleuth Consulting Services, LLC Unlike many of my colleagues, I work as an Independent Medical Librarian . . . a liaison to people of diverse information needs, not necessarily local to WA. I am the principal of Biosleuth Consulting Services, ...
Source: Dragonfly - October 30, 2017 Category: Databases & Libraries Authors: Carolyn Martin Tags: News from Network Members Medical Librarians Month Source Type: news

MSLs: The Superheroes of Pharma?
The Medical Science Liaison (MSL) has come a long way in a short time. While pharma never stands still for long, the need for scientifically credible partners to help customers understand the growing complexity of new medicines and navigate the choppy waters of real-world evidence and health outcomes, has seen the MSL come to the fore in ways few might have imagined.While the core competencies of the MSL remain unchanged, new capabilities will be needed – both for MSLs and MSL leaders – to meet the demands of the changing roles. But what does the modern MSL look like and what skills will they need now and in th...
Source: EyeForPharma - October 25, 2017 Category: Pharmaceuticals Authors: Lucy Fulford Source Type: news

Building a medical map of the body
Medical science can seem to zig and zag from one study to the next.?One study says one thing while another study appears to contradict it. What may not be obvious is that, behind the apparent contradictions, is a process called the scientific method. Over time, the scientific method, starting with basic research, straightens out these [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - October 25, 2017 Category: Databases & Libraries Source Type: news

The Guardian view on gene therapy: money well spent | Editorial
A rare and fatal disease will be now treated on the NHS. But the real problems come from common and unglamorous complaintsThe NHS is tofund a very expensive treatment for a very rare but terrible childhood disorder that leaves babies condemned to life in a sterile bubble. This is a triumph for medical science but it should also provoke some deep and careful thought. The treatment in question, strimvelis, qualifies as the second most expensive drug ever put on the market (the only one more expensive waswithdrawn due to lack of demand). A single dose costs nearly £500,000 plus VAT, and can only be administere...
Source: Guardian Unlimited Science - October 23, 2017 Category: Science Authors: Editorial Tags: Medical research Stem cells Genetics Biology Science NHS Health Society Children UK news Source Type: news

Innovative Research and the Opioid Epidemic: Are We Closer to Finding Solutions?
Research America. 10/13/2017 This one-hour, two-minute webinar discusses the role of research in the opioid crisis, implications for public health, the role of pharmacists in addressing the crisis, and how medical science and public health are addressing the issue. Speakers highlight the importance of facilitating recovery between overdose hospitalizations and treatment, noting that emergency departments and incarceration facilities represent opportunities to start opioid abuse patients on medication-assisted therapy, which reduces opioid cravings and alleviates opioid withdrawal symptoms. (Video or Multimedia) (Source: Di...
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - October 20, 2017 Category: International Medicine & Public Health Authors: The U.S. National Library of Medicine Source Type: news

ESnet's science DMZ design could help transfer, protect medical research data
(DOE/Lawrence Berkeley National Laboratory) As medicine becomes more data-intensive, Berkeley Lab& ESnet's Medical Science DMZ eyed as secure solution for transferring data. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 16, 2017 Category: International Medicine & Public Health Source Type: news

Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff
This is a Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff (Source: What's New at CBER)
Source: What's New at CBER - October 13, 2017 Category: Biomedical Science Source Type: news

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry
This is the Draft Guidance for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry (Source: What's New at CBER)
Source: What's New at CBER - October 13, 2017 Category: Biomedical Science Source Type: news

The Recommended Dose podcast launches
The Recommended Dose launches today with one of the world ’s most influential doctors, BMJ editor-in-chief Fiona Godlee calling for a move away from drug company-funded science – towards a more independent evaluation of medicines.Multi-award-winning journalist and health researcher Dr  Ray Moynihan today launched a compelling new podcast series produced by Cochrane Australia.‘This new series tackles the big questions in health and offers new insights  evidence and ideas from some of the world’s most fascinating and prolific researchers, writers and thinkers,’ says Ray. ‘Its aim...
Source: Cochrane News and Events - October 13, 2017 Category: Information Technology Authors: Muriah Umoquit Source Type: news

UTokyo NY Conference to headline studies on deadly viruses, Alzheimer's
(University of Tokyo) Leading scientists from Japan in the fields of medical science and industrial science will speak at the UTokyo NY Conference on Friday, November 3, 2017, to report on their international collaboration projects on deadly viruses and Alzheimer's prevention. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - October 11, 2017 Category: Infectious Diseases Source Type: news

Many new cancer drugs don't save lives
Here's this week's roundup of eclectic and under-the-radar health and medical science news. (Source: CBC | Health)
Source: CBC | Health - October 7, 2017 Category: Consumer Health News Tags: News/Health Source Type: news

Package Insert - TWINRIX
(Source: What's New at CBER)
Source: What's New at CBER - October 3, 2017 Category: Biomedical Science Source Type: news

Francis Crick Institute looks to turn discoveries into treatments
Former BP boss John Browne becomes chairman of £650m biomedical science centre (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - October 1, 2017 Category: Pharmaceuticals Source Type: news

SOPP 8406: CBER Processing of PDUFA Application Payments
This document describes the procedures used to determine the accuracy of information submitted by an applicant and to verify user fee payments relative to the Prescription Drug User Fee Act (PDUFA) of 1992, as reauthorized by the Food and Drug Administration Amendments Act of 2007. In addition, this document identifies other user fee activities for which the Office of Management ’s Regulatory Information Management Staff (RIMS) is responsible. (Source: What's New at CBER)
Source: What's New at CBER - September 29, 2017 Category: Biomedical Science Source Type: news

Anti-B (Murine Monoclonal)
(Source: What's New at CBER)
Source: What's New at CBER - September 28, 2017 Category: Biomedical Science Source Type: news

If blueberries were pharmaceuticals, they would be hailed as the greatest "miracle" health breakthrough in the history of medicine
(Natural News) Blueberries are miraculous natural medicine. If they were prescription medications, they would be called a “miracle” health breakthrough and an unprecedented milestone in medical science. Yet you can get them without a prescription, without a visit to the doctor and without “permission” from your health insurance provider. And unlike toxic prescription medications, blueberries... (Source: NaturalNews.com)
Source: NaturalNews.com - September 23, 2017 Category: Consumer Health News Source Type: news

New Grant Will Examine Link Between ‘Dirty’ Brains and Alzheimer’s
A new $3.2 million grant will bring together biomedical scientists and mechanical engineers in an effort to develop a detailed understanding of the brain ’s waste removal system. The research could have significant implications for diseases like Alzheimer’s that arise when this system breaks down and toxic proteins accumulate in the brain. (Source: University of Rochester Medical Center Press Releases)
Source: University of Rochester Medical Center Press Releases - September 20, 2017 Category: Universities & Medical Training Authors: University of Rochester Medical Center Source Type: news

Privigen
(Source: What's New at CBER)
Source: What's New at CBER - September 18, 2017 Category: Biomedical Science Source Type: news

Beware of hype in medical science
They may be the original 'spin' doctors. A new study finds that a surprising number of medical researchers can’t resist hyping their conclusions. (Source: CBC | Health)
Source: CBC | Health - September 11, 2017 Category: Consumer Health News Tags: Radio/White Coat, Black Art/Blog Source Type: news

Abbott Prism Chagas
The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens. (Source: What's New at CBER)
Source: What's New at CBER - September 11, 2017 Category: Biomedical Science Source Type: news

Viral Networks: An Advanced Workshop in Digital Humanities and Medical History
Join the National Library of Medicine, supported by the National Endowment for the Humanities (NEH) through a grant to Virginia Tech, for this exciting opportunity! On January 29-30, 2018, NLM will host Viral Networks: An Advanced Workshop in Digital Humanities and Medical History, bringing together scholars from various fields of medical history whose innovative research shows promise through the use of methods, tools, and data from the digital humanities. Viral Networks will combine a face-to-face workshop with structured virtual-editing activities to produce and advance the innovative scholarship of the participant...
Source: NN/LM Middle Atlantic Region Blog - September 11, 2017 Category: Databases & Libraries Authors: Hannah Sinemus Tags: Data Science Education News from NLM/NIH Technology Source Type: news

WinRho SDF Liquid
Updated Package Insert, Patient Information and " Dear Healthcare Provider " Letter with Drug Warning Information. Updated: January 26, 2010. (Source: What's New at CBER)
Source: What's New at CBER - September 8, 2017 Category: Biomedical Science Source Type: news

Protein Paradox
Molecular biophysicist Enrique De La Cruz studies how a chain of molecules strong enough to support a cell can break so easily —and uses props to help others understand what he’s learned.Read more. (Source: NIGMS Findings)
Source: NIGMS Findings - September 7, 2017 Category: Biomedical Science Source Type: news

The Science of Size
Cell biologist Rebecca Heald studies the factors that determine an animal ’s size.Read more. (Source: NIGMS Findings)
Source: NIGMS Findings - September 7, 2017 Category: Biomedical Science Source Type: news

Spotlights on Hot Science
Learn about new basic biomedical research discoveries, potential treatments for patients, scientific trends and tools for doing cutting-edge science.Read more. (Source: NIGMS Findings)
Source: NIGMS Findings - September 7, 2017 Category: Biomedical Science Source Type: news

SECOND OPINION | The demise of a dietary dogma?
Second Opinion is a weekly roundup of eclectic and under-the-radar health and medical science news. (Source: CBC | Health)
Source: CBC | Health - September 2, 2017 Category: Consumer Health News Tags: News/Health Source Type: news

New assessment predicts fracture risk for patients in long-term care
(Hebrew SeniorLife Institute for Aging Research) Researchers from Hebrew SeniorLife's Institute for Aging Research have developed and validated a new assessment to predict the risk of falls in long-term care patients. The study on the assessment titled 'Fracture Risk Assessment in Long Term Care (FRAiL)' was published today in the Journal of Gerontology Medical Science. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - August 31, 2017 Category: International Medicine & Public Health Source Type: news

Diphtheria and Tetanus Toxoids Adsorbed
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news

Benefix
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news

ReFacto
(Source: What's New at CBER)
Source: What's New at CBER - August 28, 2017 Category: Biomedical Science Source Type: news

TachoSil
(Source: What's New at CBER)
Source: What's New at CBER - August 24, 2017 Category: Biomedical Science Source Type: news

DNA sensor system developed for specific and sensitive measurement of cancer-relevant enzyme activity
(Aarhus University) The development of DNA sensor systems is of great importance for advances in medical science. Now another piece of the puzzle for the development of personalized medicine has been found with the results of a highly sensitive monitoring of cancer-related topoisomerase II enzymes. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - August 23, 2017 Category: Cancer & Oncology Source Type: news

NIH grant to biomedical scientist will advance research on inflammatory bowel disease
(University of California - Riverside) Declan McCole, a biomedical scientist at the University of California, Riverside, has received a $1.83 million grant from the National Institutes of Health to identify how the loss of a protective barrier in the intestine contributes to inflammatory bowel disease (IBD). IBD is a chronic inflammatory disease of the intestine that includes Crohn's disease and ulcerative colitis. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 11, 2017 Category: International Medicine & Public Health Source Type: news

A personalized approach to Alzheimer's disease prevention
(American Geriatrics Society) In a new study, published in the Journal of the American Geriatrics Society, James E. Galvin, MD, MPH, Professor of Integrated Medical Science and Associate Dean for Clinical Research, Charles E. Schmidt College of Medicine, Florida Atlantic University, examined potential Alzheimer's disease prevention strategies. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 9, 2017 Category: International Medicine & Public Health Source Type: news

RCMI Translational Science 2017
October 28-November 1, 2017 Washington, DC. RCMI 2017 presents opportunities to share new and innovative approaches toward eliminating health disparities, developing the next generation of biomedical scientists, and extending the reach and visibility of the RCMI community by engaging NIMHD and NIH grantees with research interests in health disparities. (Source: HSR Information Central)
Source: HSR Information Central - August 3, 2017 Category: International Medicine & Public Health Source Type: news

Cochrane seeks Managing Editor for Cochrane Infectious Diseases Group - Liverpool, UK
The Department of Clinical Sciences has an exciting opportunity for a Managing Editor to work in  the Cochrane Infectious Diseases GroupThe Liverpool School of Tropical Medicine (LSTM) is an internationally recognised centre of excellence for research in tropical diseases.   This includes the Centre for Evidence Synthesis in Global Health, which houses the Cochrane Infectious Diseases Group (CIDG), one of the first Cochrane Groups and highly successful, and well known for its exacting standards.As the Managing Editor of CIDG you will help organize review production across over 600 authors from some 52 countries. ...
Source: Cochrane News and Events - August 1, 2017 Category: Information Technology Authors: mumoquit at cochrane.org Source Type: news

A new reason to worry about teenage drinking
A look at how teen drinking could contribute to obesity, and a scientist's battle against the marketing unproven stem cell therapies. Read our weekly roundup of eclectic and under-the-radar health and medical science news. (Source: CBC | Health)
Source: CBC | Health - July 29, 2017 Category: Consumer Health News Tags: News/Health Source Type: news

New book on prion diseases from Cold Spring Harbor Laboratory Press
(Cold Spring Harbor Laboratory Press) 'Prion Diseases' covers the progress that has recently been made in our understanding of the pathophysiology of prion diseases, as well as ongoing efforts to develop effective therapeutics. The contributors discuss how proteins such as tau, islet amyloid polypeptide, andα-synuclein adopt alternative shapes that lead them to aggregate, resulting in cellular degeneration. This volume is therefore useful for all biomedical scientists and physicians wishing to understand and treat this group of devastating disorders. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 27, 2017 Category: International Medicine & Public Health Source Type: news