Tuesday, September 23, 2014

What You Should Know for the 2014-2015 Influenza Season | Seasonal Influenza (Flu) | CDC

Read the full fact page: What You Should Know for the 2014-2015 Influenza Season | Seasonal Influenza (Flu) | CDC:

"People should begin getting vaccinated soon after flu vaccine becomes available, ideally by October, to ensure that as many people as possible are protected before flu season begins."

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Monday, September 22, 2014

Five Steps That Men Can Take to Avert a Heart Attack - NBC News.com

Read the full article: Five Steps That Men Can Take to Avert a Heart Attack - NBC News.com:

"Men who take just five healthy steps can reduce their odds of a heart attack by four-fifths, but just 1 percent of men do so on their own, according to new research published Monday. The steps are nothing secret: They are not smoking, drinking moderately, exercising daily, eating a healthy diet and keeping the belly in check."

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Saturday, September 20, 2014

FDA to Middle-Aged Men: You Probably Don’t Need Testosterone Therapy - MensJournal.com

Read the full article: FDA to Middle-Aged Men: You Probably Don’t Need Testosterone Therapy - MensJournal.com:

" A recent study found that testosterone therapies doubled the heart attack risk for men over age 65 and for younger men with a history of heart disease after only three months of use. And in June the FDA began requiring drug manufacturers to include a warning label on product packaging, stating that these treatments may cause blood clots.

Schwartz says they may also increase PSA levels, an indicator of prostate cancer risk, although they haven’t been proven to increase the risk. “Given these potential harms and the fact that these are unproven therapies for men with low T of aging,” she says, “what’s going on right now is a huge uncontrolled experiment.”"

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Friday, September 12, 2014

Hallucinogen in 'magic mushrooms' helps longtime smokers quit in Hopkins trial | Hub

Read the full article: Hallucinogen in 'magic mushrooms' helps longtime smokers quit in Hopkins trial | Hub:

"Johns Hopkins researchers report that a small number of longtime smokers who had failed many attempts to drop the habit did so after a carefully controlled and monitored use of psilocybin—the active hallucinogenic agent in so-called "magic mushrooms"—in the context of a cognitive behavioral therapy treatment program.

The abstinence rate for study participants was 80 percent after six months, much higher than typical success rates in smoking cessation trials, says Matthew W. Johnson, an associate professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, and the corresponding author on the study."

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Thursday, September 11, 2014

Health Canada: We do not enforce the law when Canadians poison Americans - Searching for Safety

Read the full article: Health Canada: We do not enforce the law when Canadians poison Americans - Searching for Safety:

"Simply put, Health Canada admits that it does not intend to enforce the law on Canadian internet pharmacies that sell to foreigners.  We suspected this was the excuse, but now it’s official. As Health Canada’s response says:
Health Canada prioritizes its work according to the risk to health that the incident may pose to Canadians. Incidents that present a potentially higher risk to health will be actioned first. Incidents of low or nominal risk will be assessed and entered into our tracking system for possible future compliance action as deemed appropriate."
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Sunday, September 7, 2014

New Influenza drug Peramivir by BioCryst Pharma Treats Flu in One Dose | Capital OTC

Read the full article: New Influenza drug Peramivir by BioCryst Pharma Treats Flu in One Dose | Capital OTC:

"According to latest studies, a single dose of new antiviral drug Peramivir is safe and effective in treating influenza in adults when it is administered within 48 hours of the appearance of the symptoms of Flu."

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Saturday, September 6, 2014

More deadly pathogens, toxins found improperly stored in NIH and FDA labs - The Washington Post

Read the full article: More deadly pathogens, toxins found improperly stored in NIH and FDA labs - The Washington Post:

"Officials at the National Institutes of Health said Friday a search on their sprawling Bethesda campus had turned up five different misplaced biological materials in recent weeks. All of them are considered so dangerous — they are known as “select agents” — that the government requires them to be stored in specially secured facilities. But in these cases, the vials were in regular labs, often part of collections of samples that date back decades.

Simultaneously, the Food and Drug Administration said it had found vials of staphylococcal enterotoxin, a frequent cause of food-borne illness, at a lab within the agency’s Center for Food Safety and Applied Nutrition that was not registered to handle it."

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Friday, September 5, 2014

Biotechnology to the Rescue - US News

Read the full article: Biotechnology to the Rescue - US News:

"The life sciences industry is in the middle of a historic boom, churning out new medical weapons at an unprecedented pace. In 2012, the Food and Drug Administration approved 39 “new molecular entities,” completely novel drugs to treat everything from cancer to tuberculosis to HIV. It topped that off by adding 27 more last year, and there are now more than 4,000 investigational medicines in the pipeline.

Medical device-makers are also in high gear; the 33 products approved in 2013 include replacement hips, new cardiac stents and prosthetic spinal discs. Here’s a sampling of the most innovative developments transforming medical practice and offering patients new hope:"

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Tuesday, September 2, 2014

Company tests a way to deliver vaccines by a skin 'patch' - Boston Business Journal

Read the full article: Company tests a way to deliver vaccines by a skin 'patch' - Boston Business Journal:

"An Australian biotech startup with an office in Cambridge's Kendall Square has developed a way to deliver vaccines to patients without using a syringe or nasal mist. Vaxxas Inc. has developed the Nanopatch, which consists of thousands of vaccine-coated microprojections that penetrate the outer layers of a patient’s skin.

The nano-level sized microprojections are coated with vaccine and then released directly to key immune cells found just below the skin’s surface, according to Vaxxas CEO David Hoey."

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Thursday, August 21, 2014

UAVs Give New Meaning To Drug Delivery - Med Device Online

Read the full article: UAVs Give New Meaning To Drug Delivery: - Med Device Online

"A Palo Alto- and London-based startup company is developing unmanned aerial vehicle (UAV) technology with a new twist. Instead of performing remote surveillance or delivering explosives with surgical accuracy, they distribute payloads of medical supplies.

Reaching remote areas in developing countries can be difficult, especially in times of disaster. Roads may not be accessible, or a region may be quarantined due to an infectious disease "

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What? No More Annual Pelvic Exams? - Medscape

Read the full article: What? No More Annual Pelvic Exams? - Medscape:

"No More Routine Pelvic Exams...Really?

I am a female general internist. I provide well-woman screening -- including "the" pelvic exam -- for the vast majority of my patients. That's why new clinical practice guidelines from the American College of Physicians (ACP),[1] based on a comprehensive systematic review of 68 years' worth of English-language evidence, really caught my eye. I read ACP's strong recommendation: "ACP recommends against performing screening pelvic examination in asymptomatic, nonpregnant, adult women." My first thought was, "Really?""

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FDA, GMPs, QSR, GCP, GLP, GXP:
21 CFR Parts 210 and 211: Drug Industry GMP's     Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)     The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices     Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)     How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations     Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance     How to Develop and Manage Qualification Protocols for FDA Compliance         Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)     Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices     FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics     Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)     Clinical Studies Management: A Practical Guide to Success     Analytical Chemistry in a GMP Environment: A Practical Guide     Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)     Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook     Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)     Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)     Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition     Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)     Cleaning Validation: A Practical Approach     Validated Cleaning Technologies for Pharmaceutical Manufacturing     Risk-Based Compliance Handbook     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)     Bioprocess Validation: The Present and Future     Laboratory Validation: A Practitioner's Guide     Quality Assurance Workbook for Pharmaceutical Manufacturers     Risk-based Software Validation: Ten Easy Steps     ISO 13485 and FDA QSR Internal Audit Checklist     ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees     Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition     50 Creative Training Openers and Energizers     Personalized M&M Candies     Oriental Trading Co - Training toys and supplies     GMP Training Gifts & Giveaways     GMP Training & Quality Posters