Wednesday, April 29, 2009

FDA - Flu Meds and Swine Flu Tests

The U.S. Food and Drug Administration (FDA), in response to requests from the U.S. Centers for Disease Control (CDC) and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test, reports this FDA news release, "FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans."

In essence, this authorizes the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, made possible by this determination and declaration of emergency, provided certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization revoked by the agency.

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Monday, April 27, 2009

FDA Makes Zometa Inj Orange Book Decision

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:


Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
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- -  original post below  - -

The Food and Drug Administration (FDA) has determined that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zoledronic acid lyophilized powder for injection, 4-mg base/vial. The Federal Register published the FDA docket "Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (pdf)."

According to IP Pharma Doc's post, Zoledronic acid (ZOMETA) lyophilized powder for injection: USFDA confirmed that drug was not withdrawn due to safety issues, this decision will allow US FDA to approve ANDA's for the innovator's (Novartis) discontinued product (in May, 2003).

Kurt Karst posts an in-depth analysis and commentary related to the FDA decision, Attention Orange Book Junkies: FDA Petition Response Cements Orange Book Preface Therapeutic Equivalence Clarification.

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Trackback URL to Kurt Karst's post:
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Saturday, April 25, 2009

Honda Exoskeletons - Are they future medical devices (video)?

Wow! Who needs a scooter in older age!? Maybe all that's needed are the very cool Honda exoskeletons that act as potential walking assist devices. Read the story and watch the videos on the Popular Mechanic site, "Will Honda's Exoskeletons turn the Elderly into RoboCops? (With Hands-On Video!). I live in a hilly city, and often think about what I'll need as I grow older. I certainly don't want to be tied to a scooter. I can imagine myself on a Segway. After seeing these demoed, I'm going to want one when my body starts to give out.

Honda Assist Exoskeleton Hands-On Video Clip

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Friday, April 24, 2009

EPA Attacks Nasty Bed Bugs!

Updated Dec 9, 2015:

Alas, the Harvard School of Public Health links in the original post didn't age well, and are invalid.

You might also be interested in this:
Infestations of bed bugs are on the increase... by Harvard Univ. (PDF)

= = =  original post follows below  = = =

I'm totally grossed out. Although I've never actually seen a bed bug, my skin crawls when I think about them. If you haven't seen one, checkout this WebMD Bed Bug Slideshow. The EPA (Environmental Protection Agency) just hosted its first meeting to figure out how to respond to the biggest bedbug outbreak since World War II. One of the problems with controlling the reddish-brown insects, according to researchers and the pest control industry, is that there are few chemicals on the market approved for use on mattresses and other household items that are effective at controlling bedbug infestations. Interestingly enough, because the registration of new pesticides takes so long, one thing the EPA could do is to approve some pesticides for emergency use. The pesticide industry will be pushing for federal funding for research into alternative solutions, such as heating, freezing or steaming the bugs out of bedrooms.

You can learn more about bed bugs here . . .

Harvard School of Public Health:
What are bed bugs?
Do bed bugs cause harm or spread pathogens (disease-causing germs)?
Where do bed bugs occur?
How do bed bugs invade a home?
How can you tell if the residence is infested?
What should you do if you find bed bugs?
What can you do to manage bed bugs?
What are your rights and obligations?
What shouldn’t you do?
How can you have specimens examined?
What should you know about insecticides and other methods for treating bed bugs?
What might you do when returning from a visit to an infested residence?

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Wednesday, April 22, 2009

Asbestos.com - HONcode Certified

I've been doing a bunch of reading on mesothelioma and asbestos these days. It's hard to find balanced information. I often rely on the HONcode certification 'seal of approval' (principles) to help me discern more trusted sources of information. I mention this because I'm trying to find information sources that I think I can trust, such as Asbestos.com - The leading mesothelioma cancer resource.

Do you rely on the HONcode?

Related Posts:
Reputable Mesothelioma Resources
Are Nanoparticles Dangerous Like Asbestos?

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Monday, April 20, 2009

FDA GCP - Tips On Conducting non-US Studies

If you're looking to conduct clinical studies outside the U.S., you might do well to read this superb article from Bruce Mackler on GEN, "Spotlight on the FDA Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues. Mackler says, "In today’s financing environment, the absence of early clinical data presents a high barrier to obtaining funding. Investors often say “show me the clinical data that show that the drug is safe and works and I will show you my money.” As a result, biopharma companies have moved into early non-U.S. clinical trials that have lower safety data burdens. These studies are being conducted in less wealthy (a.k.a., developing) countries, where Phase I trials can be more rapid and less costly. This strategy has been promoted by CROs established in these countries."

The article provides some great tips, not to be overlooked.

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Saturday, April 18, 2009

New Guidelines Released for HIV Opportunistic Infections

The first complete update in five years of the U.S. guidelines for preventing and treating HIV-associated opportunistic infections has been released by the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) and Prevention in cooperation with the HIV Medicine Association of the Infectious Diseases Society of America (IDSA). The new Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents apply state-of-the-art science and medicine to 29 infectious diseases of concern. More than 140 medical experts contributed their knowledge to this edition of the guidelines, released on April 10. These new guidelines can be viewed in either html or pdf formats:

Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (html)

or

Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (pdf)

Related Posts:
CDC Adopts 2 New HIV Intervention Approaches
HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword
HHS Updates HIV Treatment Guidelines (free pdf)

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Friday, April 17, 2009

Caution - Teeth Whiteners Can Reduce Enamel Strength

I use teeth whiteners on a regular basis, and now I'm concerned. This Medical News Today article, "Enamel Strength Affected By Dental Home Bleaching," should make you think twice about what you might be doing to the strength of your teeth. The report suggests that using teeth whiteners weakens the enamel of you teeth.

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Wednesday, April 15, 2009

Avoid FDA 510k Medical Device Clearance Mistakes - 5 Free Tips

It's better to know what's needed upfront, than to get hung up at the last moment in the 510k process. "FDA medical device approval, also known as the FDA 510k process, can easily take much longer than anticipated due to common mistakes or omissions. Here are five tips to avoid some of those mistakes," reports Nicolaas Besseling in, "Five Tips for Quick FDA 510k Clearance for Medical Devices." In a nutshell . . .

  1. Find out if the FDA regulates the device
  2. Make sure the classification of the device is correct
  3. Determine who will be the owner of the 510(k), and who will be the official correspondent
  4. Use (a) predicate device(s) that is close to the new device
  5. Pay close attention to the formatting of the submission
Following the 5 tips above won't necessarily guarantee success because there are many nuances and traps to avoid. If you're not expert in 510k filings, you might want to consider partnering with an industry consultant.

Related Posts:
Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)
FDA 510(k) Free Tips And Pearls Of Wisdom
Medical Devices - A murky 510(k) world?!

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cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

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Monday, April 13, 2009

The Medical Device Safety Act of 2009

It's a firestorm! The FDA announced that makers of certain older and risky medical devices will have to prove that their products are safe and effective according to the New York Times. This is a very hot issue. Related to this, I just read an editorial published by NEJM (the New England Journal of Medicine): The Medical Device Safety Act of 2009.

Who's side are you on? The patient? Industry? Litigation attorneys? Others?

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Saturday, April 11, 2009

Reputable Mesothelioma Resources

I've recently started to read more about mesothelioma and asbestos. I'm finding out that it's very difficult to discern what is really objective and balanced information. Here's a resource that I believe to be credible from a well-respected healthcare provider, Kaiser Permanente, "Mesothelioma." On this page, there's a good list of additional and reputable resources to explore.

What's your experience in finding fair and balanced information? Can you suggest some credible and reputable websites?

Related Posts:
Are Nanoparticles Dangerous Like Asbestos?

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Friday, April 10, 2009

Are Nanoparticles Dangerous Like Asbestos?


More recent news buzz on the topic recently. When I see nanotechnology, or nanoparticles, I'm worrying about whether we're creating a wave of manmade asbestos-like materials and ensuing mesothelioma. I stumbled across this on the NIOSH site, and think you'll find it an interesting read. Coming from NIOSH, I'm more likely to believe what I read, "Approaches to Safe Nanotechnology - Managing the Health and Safety Concerns Associated with Engineered Nanomaterials."

The document reviews what is currently known about nanoparticle toxicity, process emissions and exposure assessment, engineering controls, and personal protective equipment. This updated version of the document incorporates some of the latest results of NIOSH research, but it is only a starting point. The document serves a dual purpose: it is a summary of NIOSH's current thinking and interim recommendations; and it is a request from NIOSH to occupational safety and health practitioners, researchers, product innovators and manufacturers, employers, workers, interest group members, and the general public to exchange information that will ensure that no worker suffers material impairment of safety or health as nanotechnology develops.

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Wednesday, April 8, 2009

CAPA Problems - Most often cited 483 deficiency

You'll do well by reading this well-written article by Barbara Immel, "Converting CAPA to an Advantage - CAPA violations still generate a substantial number of warning letters. These tips can help make CAPA systems a benefit instead of a liability." Her writings are packed full of great content. Don't miss out on these pearls of wisdom and well referenced article.

In concluding, she writes, "CAPA deficiencies are one of the most common items cited in warning letters to medical device manufacturers. Therefore, it is critical for manufacturers to understand how to develop a CAPA system and how best to use it. . . ."

Related Posts:
Free FDA Compliance Library (Immel Resources LLC - Pharmaceutical, Medical Device, Biologics and Related Industries)
FDA Says - Unwise To Ignore Form 483
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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Monday, April 6, 2009

FDA - New CDRH Event Problem Codes

The FDA just published "CDRH Event Problem Codes. This CDRH website (with enhanced device and patient problem codes) provides you a PREVIEW to the updates that will be going live July 1, 2009. The FDA provides this information in advance to help you familiarize yourselves with Event Problem Code updates BEFORE the new codes ‘go live’ and are accepted in MAUDE. It's important to note that on July 1, 2009 - CDRH will begin accepting the updated codes. DO NOT submit these updated codes prior to that time because they will be rejected. Until that time FDA says to continue to use the current Event Problem Codes. April 2, 2010 is the target date to reject all inactivated and retired codes specified in this FDA update. The CDRH Event Problem Code initiative results in part, with updates to codes to reduce manufacturer reporting burden, improve adverse event report quality, and improve FDA’s ability to respond to device-related adverse events.

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Saturday, April 4, 2009

Duck - It Is A Sandbag - Flying In The MRI Room

Duck! Watch out for that flying sandbag in the MRI room. It turns out some sandbags contain metal, and they can go flying near an MRI maching, reports this FDA Medical Device Safety report, "Danger: "Sandbag" in the MRI Room." According to the article, "a patient underwent magnetic resonance imaging (MRI) while she had a sandbag on her groin to help facilitate hemostasis after a procedure that involved femoral artery puncture. The staff assumed that the bag contained only sand. As the study began, the sandbag was pulled into the MRI coil, damaging the system. Fortunately, the patient wasn’t injured, according to the report."

Bottomline, the unlabeled sandbag was found to contain ferromagnetic iron shavings and pellets. This sandbag, originally purchased for use in the hospital’s physical therapy department, shouldn’t have been brought into the MRI room.

Additional MRI Safety Resources:

  1. Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document for safe MR practices: 2007. AJR AM J Roentgenol. 2007;188(6): 1447-1474
  2. Guidance for Industry and FDA Staff: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. August 21, 2008

Related Posts:
FDA Warns - Avoid Burning - MRI and Drug Patch Interaction
Are You Safe In An MRI Machine?

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Friday, April 3, 2009

Smoking Is Too Expensive - It is time to quit

With an increase in cigarette taxes, it's no surprise many folks are deciding to quit, reports this Washington Post news article, "Cigarette Tax Rises -- And So Does Incentive to Quit." Bottomline, the most important thing a smoker can do is call this national telephone number, 1-800-QUITNOW, that connects callers to smoking cessation programs in all 50 states and D.C., and provides access to counseling and medications.

I'm glad to see a surge in quitting, it's good for everybody's health.

Related Posts:
e-Cigarettes In The News (video)
Fire Safe Cigarettes Are A Good Thing
3rd Hand Tobacco Smoke - A Danger To Your Loved Ones
FDA Authority Over Tobacco - desperately needed
Menthol in Cigarettes - Cig makers might've played you! (video)

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Wednesday, April 1, 2009

Free Intro To Biomedical Engineering (videos)

This is a collection of free video lectures by Mark Saltzman of Yale, hosted on the Academic Earth website. He covers basic concepts of biomedical engineering and their connection with the spectrum of human activity. His lectures serve as an introduction to the fundamental science and engineering on which biomedical engineering is based. Case studies of drugs and medical products illustrate the product development-product testing cycle, patent protection, and FDA approval. It is designed for science and non-science majors.

This should be of some interest to those in the biotech, drug, and medical device industries.

Here's the list of his free video lectures:
Lecture 1 - What Is Biomedical Engineering?
Lecture 2 - What Is Biomedical Engineering? (cont)
Lecture 3 - Genetic Engineering
Lecture 4 - Genetic Engineering (cont)
Lecture 5 - Cell Culture Engineering
Lecture 6 - Cell Culture Engineering (cont)
Lecture 7 - Cell Communication and Immunology
Lecture 8 - Cell Communication and Immunology (cont)
Lecture 9 - Biomolecular Engineering: Engineering of Immunity
Lecture 10 - Biomolecular Engineering: Engineering of Immunity (cont)
Lecture 11 - Biomolecular Engineering: General Concepts
Lecture 12 - Biomolecular Engineering: General Concepts (cont)
Lecture 13 - Cardiovascular Physiology
Lecture 14 - Cardiovascular Physiology (cont)
Lecture 15 - Cardiovascular Physiology (cont)
Lecture 16 - Renal Physiology
Lecture 17 - Renal Physiology (cont)
Lecture 18 - Biomechanics and Orthopedics
Lecture 19 - Biomechanics and Orthopedics (cont)
Lecture 20 - Bioimaging
Lecture 21 - Bioimaging (cont)
Lecture 22 - Tissue Engineering
Lecture 23 - Tissue Engineering (cont)
Lecture 24 - Biomedical Engineers and Cancer
Lecture 25 - Biomedical Engineers and Artificial Organs

Related Posts:
Structural Aspects of Biomaterials - More than 20 free video lectures

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