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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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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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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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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FDA - New Process Validation Guidance Document

• FDA GMP QSR cGMP Training - recommended online GMP training courses by SkillsPlus International Inc.

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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