Flu.gov Updated by HHS - New Resources Added

The government's Department of Health and Human Services (HHS) unveiled several new resources on the federal government's one-stop resource for flu information -- https://www.cdc.gov/flu/. Some of the new items include:

• A self-evaluation guide
• A myth and facts section

Stay well!

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FDA Posts Current Flu Info and Resources

The FDA is doing its best to provide current information and resources about the 2009 H1N1 (Swine) Flu Virus. The following are 2 of their information-packed and massive link collections to find just about anything you can think of related to the swine flu. FDA - 2009 H1N1 (Swine) Flu Virus FDA - Influenza (Flu) Antiviral Drugs and Related Information 

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CDC Adopts 2 New HIV Intervention Approaches

According to this Medical News Today article, CDC Recognizes UCSF's Research As Critical To HIV Prevention, two HIV prevention interventions developed by UCSF researchers have been selected as additions to the Centers for Disease Control and Prevention's 2008 Compendium of Evidence-based HIV Prevention Interventions. The UCSF interventions - Positive Choice: Interactive Video Doctor and the Healthy Living Project - comprise two of the eight added to the list of 57 rigorously evaluated highly effective HIV prevention programs recommended by the CDC for implementation. As a San Franciscan and UCSF alumnus, I'm proud to see these contributions to the CDC's efforts in HIV prevention. 

Related Posts: HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video) HHS Updates HIV Treatment Guidelines (free pdf) 109 HIV Drugs And Vaccines Under Development Abzymes Pinpoint The HIV Achilles Heel

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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FDA Draft Guidance On Good Importer Practices

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Updated October 6, 2022

Several links in the original post broke.

You might also be interested in:

Draft Guidance for Industry on Good Importer Practices; Availability - Federal Register

---  the original post follows below  ---

A group of federal agencies issued a draft guidance for industry on Good Importer Practices, with the intent to help importers ensure their products are safe and comply with U.S. requirements, FDA Guidance for Industry – Good Importer Practices.

The guidance is designed to anticipate potential sources of product hazards and offer preventive controls that firms can implement to mitigate such hazards and help ensure imported products are safe and compliant with regulations. The draft is organized under 4 guiding principles . . .

1. Establishing a product safety management program
2. Knowing the product and applicable U.S. requirements
3. Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle
4. Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements

The draft guidance also recommends that:

• importers consider instituting practices to identify and minimize risks associated with imported products
• in general, importers should know the producer of the foreign products they purchase and any other manufacturers with which they do business, such as consolidators, trading companies, and distributors
• importers understand the products that they import and the vulnerabilities associated with these products
• importers understand the hazards that may arise during the product life cycle, including all stages of production, and ensure proper control and monitoring of these hazards

The agencies are issuing this draft guidance to implement recommendations outlined in the “Action Plan for Import Safety: A Roadmap for Continual Improvement,” issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the United States.

Related Posts: FDA Struggles To Keep Products From Foreign Sources Safe FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants

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Listen To People With AIDS and HIV (audio)

This is very personal. Hear eight men and women talk about their experiences with HIV and AIDS. The New York Times has other 'Patient Voices' and this one is, "Patient Voices: AIDS and H.I.V." Hearing the stories and voices of real people make the stories jump right off the page.

Prevous Posts
The Health, Drug, Prescription, and GMP Supersite: HHS Updates HIV Treatment Guidelines (free pdf)

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HHS Updates HIV Treatment Guidelines (free pdf)

Updated March 20, 2023

Get the most recent guidelines:
Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV - US Dept of HHS

- - -  the original post follows below - - -

A Department of Health and Human Services (HHS) panel has recommended two drug regimens be added to the list of preferred protease-inhibitor components in revised guidelines on the use of antiretrovirals in HIV-1-infected patients. The panel just published their revised guidelines, "
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. November 3, 2008; 1-139. These guidelines are intended to help providers make decisions about the use of antiretroviral agents.

It should be noted that these guidelines generally represent the state of knowledge regarding the use of antiretroviral agents. However, as the science rapidly evolves, the availability of new agents and new clinical data may rapidly change therapeutic options and preferences. The guidelines, therefore, are updated frequently by the Panel.

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September is National Alcohol and Drug Addiction Recovery Month

President Bush just proclaimed it. Join the voices of recovery, during September, the National Alcohol and Drug Addiction Recovery Month (check out this HHS website). There are a number of great resources available to you . . .

1. Recovery Month Kit
2. The Road to Recovery 2008 Public Service Announcements
3. Webcasts
4. . . . and so much more!

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Menthol in Cigarettes - Cig makers might've played you! (video)

View the MSNBC video above or read this NY Times article, "Study Finds Manipulation of Menthol Levels." If you smoke, or you've started to, you might be getting manipulated. More specifically, a just published study from Harvard states that cigarette manufacturers might be, "manipulating sensory elements of cigarettes to promote initiation and dependence." If you need help to stop smoking (smoking cessation), here's a good place to start, Smoking and Tobacco Use -How To Quit (on the CDC website). 

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