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TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.
The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.
The agency said…
Added by Adam Fleming on September 21, 2017 at 6:04am — No Comments
Added by John Robinson on September 21, 2017 at 6:02am — No Comments
On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing…
Added by John Robinson on September 20, 2017 at 6:32am — No Comments
Sens. Lindsey Graham of South Carolina and Bill Cassidy of Louisiana have drafted the latest Republican attempt to repeal Obamacare. The bill would overhaul or eliminate major sections of the health care law, including its subsidized insurance coverage and Medicaid expansion. Instead, states would receive block grants, or a lump sum of money from the federal…
Added by John Robinson on September 20, 2017 at 6:29am — No Comments
In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice…
Added by Adam Fleming on September 20, 2017 at 6:27am — No Comments
About Nitinol-based Medical Devices
Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…
ContinueAdded by Adam Fleming on September 19, 2017 at 6:05am — No Comments
One in every seven men in the United States will get prostate cancer, making it the second most common type, after skin cancer, for American men. It tends to be a slow-growing disease, but can sprint to life-threatening severity if detected too late. Screening for prostate cancer can yield false-positive findings, but those most at risk for the disease—men whose father or a brother had prostate cancer, African American men, overweight men, and those in their 60s and 70s who are in good…
ContinueAdded by John Robinson on September 19, 2017 at 5:54am — No Comments
PA&E works with leading medical implant designers to advance integration and performance for hermetic implantable packaging and connectors in one of the most unique and critical environments known: the human body.
PA&E has created proprietary materials and encapsulations with hermetic seals that enable implantable medical…
Added by John Robinson on September 19, 2017 at 5:51am — No Comments
And the damage to the heart and blood vessels can occur in youth at blood pressure levels that are below the clinical definition of hypertension in youth.
High blood pressure in youth is defined differently than it is in adults. In childhood, high blood pressure is based on percentiles, rather than blood pressure level. Researchers looked at…
Added by John Robinson on September 18, 2017 at 7:45am — No Comments
After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again.
A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible…
Added by John Robinson on September 18, 2017 at 7:42am — No Comments
For people on a job hunt, the reason for not offering one is almost invariably the same: You lack experience. How do you convince the organization that one can gain no experience unless one has a job? This is a typical chicken and egg conundrum: You are not given a job because you have no experience, and you have no experience because you don't get a…
ContinueAdded by Roger Steven on September 18, 2017 at 6:52am — No Comments
Some of the functions of medical device manufacturers include:
o Analyzing complaints
o Processing data
o Evaluating nonconformances
o Utilizing other quality data sources.
The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…
Added by Adam Fleming on September 18, 2017 at 6:49am — No Comments
Disasters, which can ultimately lead to a data breach, come in various forms – natural, man-made and technical. HIPAA, the HITECH Act, the Federal Trade Commission and the Securities and Exchange Commission are just a handful of entities requiring that the confidentiality, integrity and availability of the sensitive information (e.g., protected health information (PHI) and personally identifiable information (PII)) remain intact. Although federal HIPAA has distinct…
Added by John Robinson on September 15, 2017 at 6:46am — No Comments
The position of the corporate controller, or company controller, has become an important one in companies today. This is a role that has come into being following the evolution of the corporate setup, which has brought with it many changes. The corporate controller has come into existence because of these changes.
In simple terms, the corporate controller is one who can be defined as the chief accounting officer. She is to accounting what the chief…
ContinueAdded by John Robinson on September 15, 2017 at 6:43am — No Comments
What, in your estimate, is the cost of taking up a career in compliance? Thousands of dollars? Hundreds? Well, none of these! If you are considering a career in compliance, join our $10 training online! Yes, $10 is all that it costs for you to start a career in compliance!
Who is offering this monstrous offer, and why? Let us explore this a bit for you: GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, has come up with an…
ContinueAdded by John Robinson on September 15, 2017 at 6:06am — No Comments
Obesity is one of the biggest causes of non-communicable, lifestyle diseases today. According to the World Health Organisation, close to 1.9 billion adults were obese in the year 2014. Around 2.8 million people die due to some complications associated with obesity every year. A recent study published in the Journal of the American College of Cardiology notes that obese people who may otherwise be healthy and free from ailments like diabetes, hypertension, et cetera may still run at…
Added by John Robinson on September 13, 2017 at 6:45am — No Comments
LONDON, Sept 13 (REUTERS) – Proposed United States budget cuts could put in jeopardy great progress in reducing global poverty and disease and lead to 5 million more deaths from AIDS alone, the philanthropist Bill Gates warned on Wednesday.
Gates, whose Bill and Melinda Gates…
Added by John Robinson on September 13, 2017 at 6:38am — No Comments
Added by John Robinson on September 12, 2017 at 6:10am — No Comments
Pharmaceutical companies gave Australian doctors, nurses and pharmacists almost $12m in fees and expenses to attend conferences and give talks between November 2016 and April 2017.
The payments comprised more than $6.5m for travel expenses and accommodation; more than $4.2m in speaking and consultancy fees; and more than $700,000 to cover registration at medical conferences and events.
The drug companies Bristol-Myers Squibb and…
Added by John Robinson on September 12, 2017 at 6:07am — No Comments
The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an…
Added by Adam Fleming on September 12, 2017 at 5:59am — No Comments
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