CDC: 25 states, including Va., reporting widespread flu | WTVR.com

English: Logo of the Centers for Disease Control and Prevention, an agency within the United States Department of Health and Human Services. White on blue background with white rays but no white "burst". No detailed wording. (Photo credit: Wikipedia)

CDC: 25 states, including Va., reporting widespread flu | WTVR.com:

"The number of states reporting widespread seasonal flu activity jumped from 10 to 25 last week, the Centers for Disease Control and Prevention said Friday.

Widespread activity was reported in Alabama, Alaska, Arkansas, Colorado, Connecticut, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Nebraska, Nevada, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington state and Wyoming, according to the CDC’s weekly flu advisory report, covering the week ending December 28.

“Widespread” means that more than 50% of geographic regions in a state — counties, for example — are reporting flu activity. It addresses the spread of the flu, not its severity."

'via Blog this'

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2014 GMP Training Ideas - Deviation Investigation Report Writing Workshop

483 Observation Gotchas!

1. Deviation reports failed to include a discussion of product impact.

2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.

3. Investigation reports failed to provide data to support the root cause determination

Planning for Training 2014!  2014 is just around the corner!  Do your investigation reports wander all over and never get to the point, or Do deviation reports fail to document a sound root cause conclusion, or Do deviation report writers never seem to know what Quality Assurance wants discussed in the report? If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic. Learn More About the SkillsPlus Investigation Report Writing Clinic

Featured Course Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered. Common sections addressed in this very popular workshop: 1. Deviation Description 2. Previous Related Investigations 3. Product Impact Assessment 4. Root Cause Investigation Discussion 5. Root Cause Determination 6. Risk Assessment 7. Corrective and Preventive Actions and more! If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic! Examine The SkillsPlus Investigation Report Writing Clinic Outline

Allan Dewes, President. About Your Instructor Allan Dewes Allan Dewes has been teaching others to write deviation investigation reports for over 15 years. Allan understands CGMP regulations, the FDA expectations for deviation investigation reports, and how to coach others to write a quality document. Email today to request a quotation

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

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Put fun back into GMP training!

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UN World Drug Report 2013 - Alarming rise in NPS

The acronym NPS stands for new psychoactive substances.

World Drug Report: stability in use of traditional drugs, alarming rise in new psychoactive substances:

"This is an alarming drug problem - but the drugs are legal. Sold openly, including via the internet, NPS, which have not been tested for safety, can be far more dangerous than traditional drugs. Street names, such as "spice", "meow-meow" and "bath salts" mislead young people into believing that they are indulging in low-risk fun. Given the almost infinite scope to alter the chemical structure of NPS, new formulations are outpacing efforts to impose international control. While law enforcement lags behind, criminals have been quick to tap into this lucrative market. The adverse effects and addictive potential of most of these uncontrolled substances are at best poorly understood."

For more information:
World Drug Report 2013

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FDA Should Revamp 510(k) Medical Device Clearance Process

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Updated November 4, 2022

Some of the links broke.

You can still read about the same topic here:

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years - NAP.edu

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The LA Times reports, FDA is urged to revamp its review process for medical devices.

In a nutshell, the Institute of Medicine (IOM), an arm of the National Academy of Sciences (NAS), recommended that the system be abolished and new procedures established, IOM - Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.

Webcast of the Institute of Medicine - Public Health Effectiveness of the FDA 510(k) Clearance Process - Public Briefing (July 29, 2011)

FDA and EPA Nuclear Radiation Monitoring

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Here's a better set of webpages that offer information about possible nuclear radiation reaching the United States.

Joint EPA/FDA Statement: Update on Ongoing Monitoring - on steps taken to increase the level of nationwide monitoring of milk, precipitation, drinking water, and other potential exposure routes.

Japanese Nuclear Emergency: EPA's Radiation Air Monitoring - home page

EPA's RadNet Monitoring Data - a map of radiation monitoring stations

EPA - Daily Data Summary - from the EPA's RadNet Monitoring Data

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More Aspirin Benefit - Cancer Prevention - I Love It

I started taking a daily dose of aspirin well over a decade ago, in hopes that the anecdotes of cancer prevention benefit would one day morph into evidence-based data. Voila!



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Drugs and Supplements From China Still Largely Unregulated

• Pro Tip:  FDA GMP QSR cGMP Online Training - highly recommended GMP online training courses offered by SkillsPlus International Inc.

Updated February 9, 2021

Links in the original post broke.

People also ask about:

Safeguarding Pharmaceutical Supply Chains in a Global Economy - FDA.gov

- - -  original post follows below  - - -

Probably not surprising, and certainly disappointing, as reported by this KansasCity.com news article, Drugs, supplements come to U.S. from China largely unregulated.

I'm most concerned about, "One consequence of the lack of regulation has been a rising number of counterfeit drugs."

Related links:
GAO Report Blasts FDA for Failure to Implement 2008 Recommendations

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Univ of CA CMCR - Evidence Cannabis Is A Promising Treatment

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The Center for Medicinal Cannabis Research: Report to the California Legislature (2010) - pdf reports:

"The CMCR has successfully conducted the first clinical trials of smoked cannabis in the United States in more than 20 years. As a result of this program of systematic research, we now have reasonable evidence that cannabis is a promising treatment in selected pain syndromes caused by injury or diseases of the nervous system, and possibly for painful muscle spasticity due to multiple sclerosis."

Learn More:
Understanding Marijuana: A New Look at the Scientific Evidence

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Biotechnology Trends 2010 - Free Report

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Here's the next installment of my hunt for 2010 trends, forecasts, and predictions. Pharma-Reports.com just announced the availability of its executive report, Biotechnology Trends 2010 (free). I've provided the link to the request form. The report examines the most significant trends in biotechnology and their impact on rising health care costs, the aging population, and an overall rise in the incidence of disease. The report also discusses scientific advancements in proteomics and biomarkers, molecular manufacturing, and the development of smart materials.

Previous Posts: Looking Ahead to Pharma 2010 - Through the IBM innovation lens GMP Training - The end is near - I mean 2009! IMS Predicts Pharma Growth in 2010 CDC - Brand New 2010 Yellow Book for Travelers - free - online 

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Bah Humbug - Oh, that should be Bed Bug!

I just read a newspaper article reporting that users of http://www.bedbugregistry.com/ have been reporting the most complaints in Toronto and Vancouver. I checked out the "registry" and find it both fun and enlightening. Check it out! 

Previous Posts: EPA Attacks Nasty Bed Bugs! College Students - eccch, dorm room bedbugs! (video) 

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FDA Reports Latest List of Potentially Risky Drugs

The FDA has just released its quarterly Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008. The FDA has identified potential safety issues, but this does not mean that FDA has identified a causal relationship between the drug and the listed risk. I've listed the July - Sept '08 list of affected drugs here . . . Product Name: Active Ingredient (Trade) or Product Class (Potential Signal of Serious Risk/New Safety Information)

1. Codeine-containing cough medicine (Adverse events in children)
2. Oral bisphosphonates (Esophageal cancer)
3. Mefloquine HCl (Lariam)(Psychiatric events)
4. Minocycline (Thyroid disorders)
5. Bupivicaine intraarticular injection given by infusion pump (Chondrolysis)
6. Selective serotonin and selective norepinephrine reuptake Inhibitors (SSRI and SNRI) antidepressants (Birth defects)
7. Propylthiouracil and Methimazole (Hepatotoxicity)
8. Phenytoin injection (Cardiac arrest due to rapid injectionK)
9. Terbinafine (Lamisil) oral use (Psychiatric events)

For more complete FDA information: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) Quarterly Reports 2008 January to March 2008 April to June 2008 July to September

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Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)

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The FDA and medical device industry just got a wake-up call. Seems like this GAO report suggests greater rigor is needed in the premarket review process, MEDICAL DEVICES - FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. In any event, seems like this industry sector can expect potentially more rigorous regulation in the future . . . Bottomline, the reports states, "We are recommending that the Secretary of Health and Human Services direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process." From your perspective, would more stringent regulation be a good thing? 

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109 HIV Drugs And Vaccines Under Development

Updated June 10, 2022

The original link broke.

You might also be interested in:

List of Medicines in Development for HIV 2017 - PhRMA

Biopharmaceutical Innovation in Fighting HIV/AIDS - PhRMA

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Wow! On the heels of World AIDS day, it's really heartening to see such a robust AIDS/HIV drug and vaccine pipeline. Check out this PhRMA (Pharmaceutical Research and Manufacturers of America) report, "Medicines in Development for HIV/AIDS 2008." Here are some quick hits . . .

• 29 are vaccines
• 57 are antivirals
• they are either in human clinical trials or await approval by the U.S. Food and Drug Administration (FDA)

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HIV AIDS Bone Marrow Transplant Cure - Skeptical View

Updated February 17, 2021

More current news:

Maryland HIV researcher on latest research: It's not a cure - WBAL-TV:

"Scientists used a cutting-edge stem cell transplant method to treat a woman's HIV, but a lead researcher in Maryland said it's too soon to celebrate. A U.S. woman is the third known person who is in HIV remission after receiving stem cells from umbilical cord blood, an American research team announced Wednesday."

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Updated May 1, 2021

The original link broke.

You can read more about the topic at:

Is “Cure” Still A Four-Letter Word? (PDF) - sfaf.org

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Don't get me wrong, I'm excited about this latest case report. However, there are alternate views of what this really means. See what I mean by reading this ABC Health Insider news article, "For AIDS, 'Cure' Is Still a Four-Letter Word." There are a couple of ways to think about this. If bone marrow transplantation really works in the long run, how do we make it widely available and affordable?! If it doesn't work, how long will it take to definitively confirm its ultimate failure?! What's your opinion? 

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