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The US economy’s appetite for ingesting food imports is phenomenal, to use a mild term. How else does one describe an economy that takes in $49 billion a year? Considering that the FDA is the sole regulating agency that is tasked with overseeing imports of this magnitude, who can envy its responsibility? This is not all that the FDA does: its allied regulatory agencies monitor about half a million facilities in the US and abroad.
Since foods from…
Added by Adam Fleming on November 17, 2017 at 5:23am — No Comments
The US economy’s appetite for ingesting food imports is phenomenal, to use a mild term. How else does one describe an economy that takes in $49 billion a year? Considering that the FDA is the sole regulating agency that is tasked with overseeing imports of this magnitude, who can envy its responsibility? This is not all that the FDA does: its allied regulatory agencies monitor about half a million facilities in the US and abroad.
Since foods from almost every country in the world are…
ContinueAdded by Adam Fleming on November 13, 2017 at 5:22am — No Comments
This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory…
Added by John Robinson on November 7, 2017 at 5:04am — No Comments
The Food and Drug Administration (FDA) has granted breakthrough therapy designation to GlaxoSmithKline (GSK) for its investigational B-cell mutation agent (BCMA) monoclonal antibody-drug conjugate, GSK2857916, for relapsed and refractory multiple myeloma.…
Added by John Robinson on November 7, 2017 at 5:00am — No Comments
Australia’s drug and medical device watchdog, the Therapeutic Goods Administration, needs a complete overhaul to distance it from the health industry and allow consumers to sue it for negligence, say academics and consumer advocates after the regulator quietly announced moves to classify all pelvic mesh devices high risk after years of controversy.
“The current regulatory framework is a complete bypass of the interests of consumers. They don’t have a stake…
Added by John Robinson on November 6, 2017 at 5:20am — No Comments
A few skills need to be imbibed by professionals, even if they are out of their domains or area of expertise. This is because when it comes to handling crunch situations; one cannot expect a manager to…
Added by John Robinson on November 6, 2017 at 5:17am — No Comments
What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.
These new…
Added by John Robinson on November 3, 2017 at 6:22am — No Comments
The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.
The Quality…
Added by John Robinson on November 2, 2017 at 6:49am — No Comments
Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of…
Added by John Robinson on October 31, 2017 at 6:22am — No Comments
A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday.
He is the second person to die from…
Added by John Robinson on October 27, 2017 at 7:03am — No Comments
In the dozen years from the time of its enactment, change in thinking has been one of the palpable aspects of HIPAA. The advising and counseling outlook that characterized the initial years of its existence is now history. HIPAA is today noted for its very stringent and arm-twisting attitude. Its methods of enforcement are dreaded, to put it mildly. The coaxing and wheedling method used by the Office of Civil Rights (OCR) is now passé. The OCR is extremely unrelenting in its expectations…
ContinueAdded by Roger Steven on October 25, 2017 at 7:14am — No Comments
Medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, the ISO 13485:2016, recognizes…
Added by John Robinson on October 24, 2017 at 6:54am — No Comments
Manufacturing is a behemoth of an activity that straddles several industries. Modern manufacturing has come a long way from the days of its infancy, which can be traced to the Industrial Revolution of some 250 years ago. Getting advanced and refined at many stages; production or industrialization or manufacturing is the lifeblood of most of the world’s economies. Automation in the processes may have been introduced in many industries; yet, manufacturing…
Added by Adam Fleming on October 24, 2017 at 6:20am — No Comments
As Republican efforts to repeal and replace the Affordable Care Act continue in the background, some…
Added by John Robinson on October 19, 2017 at 6:05am — No Comments
The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:
Added by John Robinson on October 12, 2017 at 6:24am — No Comments
In a scenario where today’s healthcare environment is fast paced, diverse and straddle many disciplines; retention and disposition of medical records -both paper and electronic -is fraught with complexities. There are different rules set out by the state agencies, as well as by HIPAA statutes and regulations, for the way in which medical records need to be retained…
ContinueAdded by Roger Steven on October 11, 2017 at 7:12am — No Comments
HHS withdrew three proposed rules Tuesday, including one that would have tested a new Medicare Part B drug payment model. Here are six things to know about the proposed rules. 1. CMS withdrew a proposal to test new Medicare Part B drug payment models. Medicare Part B covers prescription drugs administered in a physician’s office or hospital outpatient department. Medicare currently pays physicians and outpatient departments the average sales price of a drug, plus a 6 percent add-on. In March…
ContinueAdded by John Robinson on October 6, 2017 at 6:19am — No Comments
When a major security incident, such as the recent massive Equifax data breach, grabs headlines, CEOs start asking more questions about data security.
See Also: Addressing the Identity Risk Factor in the Age…
ContinueAdded by John Robinson on October 6, 2017 at 6:16am — No Comments
A proper understanding of the Anti-Kickback Statute (AKS) is completely necessary for healthcare providers and professionals. It is among the strongest weapons in the government arsenal for enforcing the federal fraud and abuse laws. Along with Stark II (the federal physician anti-referral law), the Anti-Kickback Statute can be and is being used as the basis for an action brought under the Federal False Claims…
ContinueAdded by Roger Steven on October 5, 2017 at 7:02am — No Comments
Education is one of the few areas nowadays that is still considered a purely sovereign matter, an issue over which national governments – and, in many countries, even local authorities – should have control. But, in today’s world, it seems that no issue is immune to political manipulation. That is the case with Ukraine’s new framework law on education, which has become the target of harsh opposition not so much from within the country, but rather…
Added by John Robinson on October 5, 2017 at 5:49am — No Comments
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