Wednesday, May 30, 2012

Bath Salts and the Naked Cannibal

I'm a little behind the times, because I'm just learning a little more about "bath salts" because of the naked man cannibal incident.

Sometimes packaged as bath salts or plant food and marketed under names such as "Purple Wave," "Vanilla Sky" and "Bliss," the stimulants are especially popular among teens and young adults and are perceived as mimics of cocaine, LSD and methamphetamine. The DEA says users have reported disorientation, extreme paranoia and violent episodes after ingesting the chemicals. They are sold on the Internet and in head shops and other retail outlets.



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Sunday, May 27, 2012

FDA Consumer Updates - Sun Safety: Save Your Skin!

The need for sun safety has become clearer over the past 30 years. Studies show that exposure to the sun can cause skin cancer. Harmful rays from the sun—and from sunlamps and tanning beds—may also cause eye problems, weaken your immune system, and give you skin spots, wrinkles, or "leathery" skin.



FDA Consumer Updates - Sun Safety: Save Your Skin!:

"Sun safety is never out of season. Summer's arrival means it's time for picnics, trips to the pool and beach—and a spike in the number of sunburns. But winter skiers and fall hikers should be as wary of the sun's rays as swimmers. People who work outdoors need to take precautions, too."

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Saturday, May 26, 2012

The Truth about a “Base Tan”

BTW, May is Skin Cancer Awareness Month.

With Memorial Day weekend upon us, the following might be of some interest to you.

The Truth about a “Base Tan” - SkinCancer.org - Sun Safety Tips for Memorial Day Weekend and Beyond :

"Those tempted to kick off summer by getting a “base tan” should be aware that there is no such thing as a safe, healthy or protective tan. The misconception that a base tan will protect the skin is dangerous; even for those who never burn, prolonged exposure to ultraviolet (UV) radiation can lead to skin aging (including wrinkles, lines and age spots) as well as skin cancer. In fact, about 65 percent of melanomas and 90 percent of nonmelanoma skin cancers are associated with sun exposure."

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Tuesday, May 22, 2012

ICH Q11 Reaches Harmonization, Implementation is Next

PharmTech Talk » ICH Q11 Reaches Harmonization, Implementation is Next:

"ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process. Q11 was published as a draft in May 2011 and reached Step 4 this month, which means that the ICH steering committee members (representing regulatory and trade organizations in the US, Europe, and Japan), have reached scientific consensus and signed the guideline. At this point, each of the region’s regulatory agencies, including FDA, will publish the guideline as official guidance within their appropriate regions and implementation will begin."

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Monday, May 21, 2012

HBO: The Weight of the Nation

The four-part 'Weight of the Nation' continues HBO's crusade for change, with a look at how obesity has affected Americans and what can be done for the long run.

HBO: The Weight of the Nation: Films: Main:



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FDA - CBER Releases Strategic Plan for 2012-2016

Just released, the FDA CBER Strategic Plan for Regulatory Science and Research

CBER Releases Strategic Plan for 2012-2016 Period - RAPS - News - Article View:

"CBER’s plan outlines six core strategic goals it says will guide it through the next five years:
  1. Increase the nation’s preparedness to address threats as a result of terrorism, pandemic influenza and emerging infectious diseases
  2. Improve global public health through international collaboration including research and information sharing
  3. Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
  4. Ensure the safety of biological products
  5. Advance regulatory science and research
  6. Manage for organizational excellence and accountability"
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Sunday, May 20, 2012

Just Throw Them Out - referring to drugs

Just Throw Them Out | The Scientist:

"The researchers compared three possible disposal methods: flushing the drugs, returning them to a pharmacy for incineration, or throwing them away. While incineration rendered the drugs completely inactive, the annual cost of a national drug take-back program could be as high as $2 billion. Flushing the drugs down the toilet would result in the highest environmental exposure to the chemicals. On the other hand, prior research had suggested that leaching from a landfill was not a significant source of pollution. Therefore, trash disposal is the simplest and most economical strategy."

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Source:
Life Cycle Comparison of Environmental Emissions from Three Disposal Options for Unused Pharmaceuticals

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Thursday, May 17, 2012

Device Manufacturing 101: Orthopedic Implants and Instruments

. . .  and don't forget about all the FDA's QSR regulations that have to be followed!

Device Manufacturing 101: Orthopedic Implants and Instruments:

". . . have you ever wondered about the steps that go into manufacturing these devices? There’s a lot of work in the process that turns an idea into an actual physical product, and often times it’s something we don’t think about.

During our recent trip to Northeast Indiana, we had the opportunity to visit a number of manufacturing sites and learn the high-tech processes and technology that go into producing orthopedic implants and instruments. Here’s how it works!"

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Association of Coffee Drinking with Total and Cause-Specific Mortality

Drinking six or more cups of coffee a day cut mortality risk the most, but not by much. People who drank between two and five cups of coffee daily also appeared to have lower risk, the study showed. Whether the coffee contained caffeine or not didn't seem to matter.

Association of Coffee Drinking with Total and Cause-Specific Mortality — NEJM:

"CONCLUSIONS
In this large prospective study, coffee consumption was inversely associated with total and cause-specific mortality. Whether this was a causal or associational finding cannot be determined from our data. (Funded by the Intramural Research Program of the National Institutes of Health, National Cancer Institute, Division of Cancer Epidemiology and Genetics.)"

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Wednesday, May 16, 2012

Home HIV test should be approved, FDA panel rules

Home HIV test should be approved, FDA panel rules - The Washington Post:

"A national poll conducted last spring by the Kaiser Family Foundation found that 44 percent of Americans between ages 18 and 65 said they had never been tested for HIV. Asked to list reasons why they had not been tested, 64 percent said they did not believe they were at risk of contracting HIV, 29 percent said their doctor had never recommended testing and 12 percent said they did not know where to go for testing."

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Monday, May 14, 2012

Is it dangerous to swallow a freshness packet from a pill bottle?

Is it dangerous to swallow a freshness packet from a pill bottle?:

"Q.When I took some medication this morning, I thought I'd accidentally swallowed the freshness packet in the vial instead of my pill. Luckily, I didn't, but what if I had? Is that dangerous?

A. No. The small paper packets or plastic packages you find in certain containers of medication, dietary supplements, and vitamins are drying agents called desiccants that contain nontoxic silica gel, a kind of sand."

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Sunday, May 13, 2012

FDA panel endorses HIV prevention drug

Melissa Harris-Perry: FDA panel endorses HIV prevention drug:



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Saturday, May 12, 2012

Should Congress Allow FDA To Give Reversible Drug Approvals?

This is thought-provoking. Perhaps a little industry-biased?!

Should Congress Allow FDA To Give Reversible Drug Approvals? - Forbes:

"Should the Food and Drug Administration be able to give drug approvals more often, then yank them if later data don’t bear out the benefits? Forbes contributor Avik Roy made exactly that argument in a recent paper for the Manhattan Institute, an industry-funded, conservative think tank where he is a senior fellow. Roy is also an adviser to the Romney campaign on health care."



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Monday, May 7, 2012

Survey Of FDA Workers Reveals Concerns About Corporate Interests In Device Approval Process

Survey Of FDA Workers Reveals Concerns About Corporate Interests In Device Approval Process:

"Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports on the results of a 2011 survey conducted by the Union of Concerned Scientists ("UCS") that showed that workers in the U.S. Food and Drug Administration's ("FDA") medical device approval section were concerned about the influence of special interests on device approval decisions.* The study, released on March 7, 2012, revealed that some workers felt pressured to approve devices even when they harbored doubts about the devices' safety. One in four of the participants answered yes to the question: "Have you ever been pressured to approve or recommend approval for a device or product despite reservations about the safety, efficacy or quality of the product?" This is especially alarming given the recent attention surrounding the FDA 510(k) device approval process, which allowed allegedly dangerous devices such as vaginal surgical mesh and certain metal hip implants to be marketed without clinical testing."

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FDA - Amendments to Sterility Test Requirements for Biological Products

This rule is effective June 4, 2012.

This rule revises the sterility requirements for most biological products under title 21 of the Code of Federal Regulations (CFR), subchapter F, parts 600 through 680 (21 CFR parts 600 through 680) [1] and is intended to promote improvement and innovation in the development of sterility test methods by allowing manufacturers the flexibility needed for sterility testing of some novel products that may be introduced to the market, enhancing sterility testing of currently approved products, and encouraging manufacturers to utilize scientific and technological advances in sterility test methods as they become available.

Federal Register | FDA - Amendments to Sterility Test Requirements for Biological Products:

"The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products."

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Tuesday, May 1, 2012

FDA Warning Letters in 2011 Mostly Focused on Batch Failures

Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures - RAPS - News - Article View:

"An analysis of US Food and Drug Administration (FDA) warning letters issued in 2011 shows the majority of all facilities receiving a warning letter were deficient in areas relating to batch failure investigation, reports In-Pharma Technologist.

“In the manufacturing-related warning letters analyzed by in-Pharma Technologist, FDA made 211 numbered observations,” of which 10% were related to the company not investigating batch failures."

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