FDA To Outsource Overseas Inspections

According to Bloomberg.com, More Outsourcing Planned for FDA Overseas Factory Inspections.

John Taylor, the FDA’s acting principal deputy commissioner, says, "We recognize that third-party inspection programs need to be a bigger part of the discussion because we can’t do all the work ourselves. We’re looking at anything, anything and everything that will allow us to leverage our resources better."

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Related articles

• US FDA device chief: More review funding needed (reuters.com)
• "FSMA: Import Rules May Foster Global Food Safety" and related posts (foodsafetynews.com)

Clinical Study Of Disulfiram To Reduce HIV Reservoir

Image via WikipediaThis caught my eye while scanning health news, Short-term Disulfiram Administration to Accelerate the Decay of the HIV Reservoir in Antiretroviral-treated HIV Infected Individuals.

This ClinicalTrials.gov notice provides robust details about the research study, which is actively recruiting participants.

I find the basis for the study pretty interesting:

"Our primary hypothesis is that disulfiram will reduce the latent reservoir of HIV-1 in patients on highly active antiretroviral therapy (HAART). Theoretically, disulfiram will force HIV to replicate (grow) and thus result in the death of the infected cell. Standard antiretroviral drugs should prevent new cells from becoming infected. The end result of this process is that the total amount of HIV in the body will decline over time."

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Related articles

• AIDS Cocktails: How They Work (webmd.com)
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• Alcohol, Cocaine Abuse Drug May Hold Clues in AIDS Cure Quest (businessweek.com)
• NIH scientists unveil characteristic of HIV early in transmission (eurekalert.org)

Battle Common Cold With Zinc

Image via WikipediaI take public transportation to work, and get a daily dousing of sneezing and hacking from fellow commuters. For that reason, I'm always on the lookout for any interventions that will keep me healthy or shorten the duration of anything contagious that I might contract.

This Washington Post article caught my eye, Got a cold? Think zinc, report concludes.

In summary:

Zinc (lozenges or syrup) is beneficial in reducing the duration and severity of the common cold in healthy people, when taken within 24 hours of onset of symptoms. People taking zinc are also less likely to have persistence of their cold symptoms beyond seven days of treatment. Zinc supplementation for at least five months reduces incidence, school absenteeism and prescription of antibiotics for children with the common cold.

Reference:
Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD001364. DOI: 10.1002/14651858.CD001364.pub3.

Something fun! You can catch (get) a cold too:  COMMON COLD GIANT MICROBE PLUSH

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• The truth about colds (cnn.com)
• Zinc May Prevent and Shorten Colds (webmd.com)

Drug Thieves Target Pharmacies

These are unfortunate times, now that drug thieves are targeting pharmacies to steal painkillers, and more.

According to this NY Times news article, Pharmacies Besieged by Addicted Thieves, the most common targets are oxycodone (the main ingredient in OxyContin), hydrocodone (the main ingredient in Vicodin) and Xanax.

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• Elmwood pharmacy targeted for OxyContin (cbc.ca)
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• Medical Treatment for Vicodin, Xanax and Oxycontin Addiction has Nearly Doubled (prweb.com)

FDA - New Process Validation Guidance Document

The FDA just published this, FDA - Guidance for Industry - Process Validation: General Principles and Practices (pdf).

In a nutshell, the CGMP regulations require that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably.

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If You're Anti-Vaccination - Then Risk Deafness, Blindness, Brain Damage or Seizures

How quickly we forget.

According to this Susan Reimer Baltimore Sun article, Vaccine refusal -- you call this cautious?:

"Childhood immunizations are victims of their own success"

Consider erring on the side of caution.

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Hangover Cure - Caffeine and Anti-Inflammatories

This just in.

Treat your hangover with caffeine and non-steroidal anti-inflammatory drugs, says this MSNBC news article, And the definitive hangover cure is ... plain old coffee and aspirin, actually.

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Preventive Anti-HIV Drug Use - Cautious Prescribing

The CDC just published, Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men.

In a nutshell:

The report provides interim guidance to health-care providers based on the reported results of the trial, which indicated that tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) taken orally once a day as preexposure prophylaxis (PrEP) is safe and partially effective in reducing HIV acquisition among MSM when provided with regular monitoring of HIV status and ongoing risk-reduction and PrEP medication adherence counseling.

You might also be interested in:
The CDC on Pre-Exposure Prophylaxis (PrEP)

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• CDC Statement On Results Of IPrEx Trial Examining Pre-Exposure Prophylaxis (PrEP) For HIV Prevention Among Men Who Have Sex With Men (medicalnewstoday.com)

FDA - 21 CFR 820 - Mobile Optimized

Need a quick way to reference the FDA's 21 CFR 820 (Medical Device regulations)?

Then checkout this mobile optimized collection of these regs, in one of two ways:

1. Go to this link:  http://breadcrumb.googleusercontent.com/view?id=ag5nbGFiczIwLXBhdmxvdnIOCxIFU3RvcnkYlZm7AQw
2. Follow the QR code, in this post.

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Icky Flu Spewers

Duh! I take a subway (MuniSF) and ride a rapid transit system (BART) to work everyday. This winter has been horrendous. I've even had to carry my own face masks.

They're spewing everywhere. What happened to manners?!

MSNBC new article, 2 in 3 Americans are icky flu spewers - As flu season kicks into high gear, survey shows we've all been 'that guy'

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• At Least 3 Died From Flu in LA County in 2011 So Far (laist.com)