Deans' stroke musings

Changing stroke rehab and research worldwide now.Time is Brain!Just think of all the trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 493 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It's quite disgusting that this information is not available from every stroke association and doctors group.
My back ground story is here:http://oc1dean.blogspot.com/2010/11/my-background-story_8.html

Tuesday, June 27, 2017

Statement on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs

It really doesn't help us at all since it did nothing to enforce the purity of supplements from the stupidity of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
https://www.mdlinx.com/endocrinology/washington-report/2017/06/27/7228653?
Silver Spring, MD, June 27, 2017––The following is a statement from FDA Commissioner Scott Gottlieb, MD, regarding the Drug Quality and Security Act:
"In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.
"The fungal meningitis outbreak underscores the need for robust oversight over human drug compounding, the importance of dispensing prescription drugs pursuant to valid prescriptions, and the need for strong coordination with state regulatory partners to protect public health.
"Since that outbreak and the subsequent enactment of the Drug Quality and Security Act (DQSA) on Nov. 27, 2013, the FDA has devoted significant resources to oversee compounding and implement the compounding provisions of the law. As of June 1, 2017, the FDA has conducted more than 400 inspections, including 109 inspections of outsourcing facilities; issued more than 150 warning letters advising compounders of significant violations of federal law; issued more than 50 letters referring inspectional findings to state regulatory agencies; overseen over 125 recalls involving compounded drugs; and worked with the Department of Justice on a number of civil and criminal enforcement actions.
"As part of the implementation of DQSA, we have also issued 21 draft guidances, 10 final guidances, three proposed rules, a final rule, and a draft memorandum of understanding. We have taken a risk–based approach to all of these efforts, in order to make sure that we are maximizing the public health purpose of these new provisions relative to the resources we use to achieve them, and any obligations that these new requirements place on market participants. These foundational regulations and guidance documents provide predictability and transparency to compounders, providers, and other enterprises; and inform them of how to comply with the law’s provisions in the most efficient manner.
"These efforts are part of our commitment to doing all we can to protect the public from poorly compounded drugs. We will continue to actively oversee drug compounders and, when appropriate, initiate regulatory action as it fulfills the FDA public health mission on behalf of patients."

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