FDA - Mobile Medical App Guidance - Will it be delayed?

Final days of waiting for FDA mobile medical app guidance? | mobihealthnews:

"Now, on the eve of the FDA’s publication of the final guidelines, the Bipartisan Policy Center and companies that include McKesson, Microsoft, Oracle, athenahealth, Epocrates, Siemens, UnitedHealth Group, Teladoc, the Silicon Valley Chapter of Health 2.0 and StartUp Health have asked HHS to delay the FDA’s final guidelines on mobile medical apps until the workgroup [FDASIA workgroup] finishes."

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Marijuana Can Damage DNA and Cause Cancer

Image by Dey via Flickr

Updated July 6, 2022

The original link broke.

You can still read about the same topic here:

Marijuana Damages DNA And May Cause Cancer, New Test Reveals - Science Daily

---  the original post follows below  ---

Sorry, here's the bad news according to this Medical New Today article, Marijuana Damages DNA And May Cause Cancer. In a nutshell, "In conclusion, these results provide evidence for the DNA damaging potential of cannabis [marijuana] smoke, implying that the consumption of cannabis cigarettes may be detrimental to human health with the possibility to initiate cancer development." 

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FDA Releases Revision To Q8 Pharmaceutical Development Guidance

The FDA released this guidance revision, Guidance for Industry Q8(R1) Pharmaceutical Development, which is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that was published in May 2006. The Q8 parent guidance is revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). This Q8(R1) document includes the Q8 parent guidance and the annex. This guidance is intended to provide guidance on the contents of section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use). 

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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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Top 10 Medical Technologies To Watch For In 2009

I love these kind of lists. Trying to peer into the crystal ball is always a most interesting exercise. Here's what the Cleveland Clinic says will shape 2009, as reported in this Chicago Tribune news article, "10 medical technologies to watch in 2009." I give you the list, and you'll want to read the full article to get a better understanding of what this means to our health and our lives. And your top ten are . . .

1. Circulating Tumor Cell Technology
2. Warm Organ Perfusion Device
3. Diaphragm Pacing System
4. Multi-Spectral Imaging Systems
5. Percutaneous Mitral Valve Regurgitation Repair
6. New Strategies for Creating Vaccines for Avian Flu
7. LESS and NOTES Applications: LESS (laparoendoscopic single-site surgery) takes laparoscopic surgery to a new level by reducing the process to a small cut in the belly button. NOTES (natural orifice transluminal endoscopic surgery) bypasses normal incisions
8. Integration of Diffusion Tensor Imaging
9. Doppler-Guided Uterine Artery Occlusion
10. Private Sector National Health Information Exchange

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HIV Treatment Goes Bionic

Bionic man. Bionic woman. Now there's bionic assassins to treat HIV. Researchers have have engineered and tested a killer T-cell receptor that is able to recognize all of the different disguises that HIV is known to have used to evade detection. The researchers attached this receptor to the killer T-cells to create genetically engineered "bionic assassins" able to destroy HIV-infected cells in culture. For the full story, read this EurekAlert, "HIV's disguises no match for 'bionic assassins' - Implications for developing new treatments for AIDS." 

Previous Posts: The Health, Drug, Prescription, and GMP Supersite: HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video) 

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