Saturday, January 31, 2009

Treat Uncomfortable Winter Itch

It feels odd for me to be talking about Winter Itch. I live in San Francisco and it's been an incredibly mild winter. Recently, highs have been in the 60s. Nonetheless, I'm prone to getting Winter Itch. This Families.com write-up can help you identify it, and treat it, Winter Itch.

You might have Winter Itch if you're experiencing . . .

  • Itching ("winter itch" isn't just a clever name)
  • Dryness
  • Flakiness
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Wednesday, January 28, 2009

And The Bis Phenol A - BPA - Melody Lingers On!

uhhhh, BPA (bis phenol A) might actually linger on for a long time in the body, reports this Plastics News article, Rochester study says BPA may linger in the body. Just when you thought it might be safe, this bit of news is worrisome. It might mean that there are more possible sources of BPA exposure running around, and/or it just hangs around in the body longer in certain tissues like fat.

Related Posts:
BPA Linked To Heart Disease And Diabetes (video)
The Health, Drug, Prescription, and GMP Supersite: Bisphenol A and the FDA - Is it safe or carcinogenic?!

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Monday, January 26, 2009

FDA Draft Guidance - Accredited Labs - Submission Packages

The FDA Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA's requirements. The guidance advises importers how to use accredited -- rather than non-accredited -- laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA. The draft guidance is also intended to reduce the likelihood that an importer will select only favorable test results to submit to the FDA.

This draft guidance supports the FDA's import strategy emphasizing prevention of harm, intervention when risks are identified, and rapid response after harm has occurred.

Related Posts:
FDA Draft Guidance - Drug Supply Chain and SNIs
FDA Draft Guidance On Good Importer Practices
Prescription Drug Reimportation and Safety - Both Presidential Candidates Support It
Hi-Tech Pharmaceuticals - Purported assassination, blackmail plots

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Sunday, January 25, 2009

Wow - FDA OKs Stem Cell Trial - This is a red letter day!

I'm thrilled to see some momentum gaining in this potentially rich area of clinical research. The U.S. Food and Drug Administration has granted clearance for Geron Corp. to begin trials for the world's first study of a human embryonic stem cell-based therapy for people. Geron said it will begin a Phase I multicenter trial designed to establish the safety of its treatment, currently referred to as "GRNOPC1," in patients with complete Grade A subacute thoracic spinal cord injuries. Read more details in this Medical News Today article, US Approves First Trial Of Embryonic Stem Cells.

I'm of the opinion that stem cell research has been stifled for way too long, and it's good to see the appearance of these studies. What's your opinion?

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Saturday, January 24, 2009

Say No To Colds - How To Wash and Dry Hands

If you're in the middle of the winter cold bug season, then read this USA Today article, The science of hand washing to ward off cold, flu bugs. We know that hands contaminated with cold or flu viruses can result in catching the bug. Bottomline, you want to wash your hands with soap and water by scrubbing well for at least 20 seconds, and alcohol hand gels are a good second choice. When drying your hands, one advantage of using paper towels, is that you can use the towel to touch a potentially contaminated bathroom door handle when exiting.

Related Posts:
Treat The Flu With Red Wine?!

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Friday, January 23, 2009

Are You Safe In An MRI Machine?

The statistics make me nervous. Your personal safety might be at risk, reports this excellent Health Care Blog post, The MRI Safety Gap. If you're headed for an MRI, you'll want to bone-up on the safety risks. It seems that more accidents and harm are happening in the MRI suite. The blog post tells the full story of flying missiles, getting burned, and more. If you're one of approximately 30 million folks (per year) getting an MRI, read the post.

For more detailed information:
JCAHO Sentinel Event Alert: Preventing accidents and injuries in the MRI suite

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HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword

Pre-exposure prophylaxis (PrEP) against HIV infection just got a huge spotlight, in this ABC News article, ABC News Examines Pre-Exposure Prophylaxis For HIV Prevention. It seems that HIV drugs taken within days after exposure to the virus have been shown to reduce the risk of infection. Part of the debate is whether approval of such pills could lead some high-risk groups to forgo safe sex practices such as condom use.

After reading this, I'm wondering if we should all be worried about prEP usage without safe sex practices. Are you worried?

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

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Thursday, January 22, 2009

FDA Draft Guidance - Drug Supply Chain and SNIs


I'm glad to see these new proposed standards. With the presence of drug counterfeiting, diversion, and quality issues, I'm hopeful these standards can bring greater safety and confidence to the supply chain. This FDA Guidance for Industry Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages - Draft Guidance is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. The details of the draft guidance follow . . .

TABLE OF CONTENTS
I. INTRODUCTION
II. BACKGROUND
A. Food and Drug Administration Amendments Act of 2007
B. Scope of this Guidance
III. STANDARDIZED NUMERICAL IDENTIFIERS
A. What should be designated as a package-level SNI?
B. Does the SNI include expiration date and/or lot or batch number?
C. Why did FDA select the serialized NDC for package-level SNI?

Do you agree with the direction this FDA draft guidance is taking us?

Related Posts:
FDA Draft Guidance On Good Importer Practices
FDA - Global Drug Supply Chain Needs Better Oversight
CA E-Pedigree - Pedigree and Serialization

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Wednesday, January 21, 2009

FDA Warning - Do Not Eat Anything With Peanut Butter! (video)


OK, it's finally come to this. The Salmonella contaminated peanut butter could be just about anywhere. And since we don't know exactly where, the FDA is warning us to avoid anything containing peanut butter, People urged to avoid peanut butter products (MSNBC News video). I have to ask myself, has this country always had salmonella contamination problems, or is the way we're handling food contributing to it? Do you know, or have an opinion?

For the latest FDA information on this peanut butter outbreak:
FDA: Salmonella Typhimurium Outbreak

Related Posts:
Pet Food Sickened People - Did they eat it? . . .
21 CFR Part 110 - cGMPs for Food - free online
FDA Salmonella Outbreak Page - it has ALL the info!
Salmonella - Peppers? Tomatoes? Both? - It is not so clear
Salmonella, Jalapenos (video and resources)
Tomatoes - Yes! Jalapenos, Serranos - uhh, no. (video)
FDA Unveils Food Protection Plan

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Tuesday, January 20, 2009

Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)

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?

Related Posts:
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FDA Draft Guidance On Process Validation
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s
FDA 510(k) Free Tips And Pearls Of Wisdom
2009 - Top 10 Trends For The Medical Equipment Market
FDA QSR Human Factors Reqs - Intro
FDA - FAQs About Combination Products
The FDA On Combination Products (drug-biologic with medical device)
Nice Review of US FDA Medical Device Regulation
6 Free FDA QSR Design Controls Tutorials
SpermCheck Vasectomy - A Home Test - Medical Device
FDA Scandal Brewing - Corrupted Scientific Reviews
Medical Devices - A murky 510(k) world?!
New FDA Guidance - New Contrast Imaging Indication Considerations

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Monday, January 19, 2009

FDA Final Guidance On Genetically Engineered Animals




The procedure of genetic engineering uses recombinant DNA for introducing new characteristics or traits into an animal. The new guidance, Guidance for Industry #187 - Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, provides all the needed details, so that the producers of these animals will know what to do in order to get the FDA's approval. Moreover, producers of these animals will also have to follow the law and regulations of the National Environmental Policy Act.

I think these are truly remarkable times in the life of scientific discovery. Do you find these advances astounding or troubling?

More Information & Related Posts:
From the FDA: Genetically Engineered Animals
Say Maaah - Goats Make Anti-Clot Drug

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Sunday, January 18, 2009

FDA Warning - Anesthetics On Skin Can Harm

According to the FDA press release, FDA Alerts Public about Danger of Skin Numbing Products, popular topical anesthetics (that is, skin numbing drugs) can cause severe reactions when used improperly. The alert talks about serious and life-threatening risks associated with improper use of topical anesthetics available in over-the-counter (OTC) and prescription forms of these drugs.

These skin-numbing products in cremes, ointments or gels contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine that are used to desensitize nerve endings near the skin's surface. If used improperly, the drugs can be absorbed into the bloodstream and cause reactions such as irregular heartbeat, seizures, breathing difficulties, coma or even death. Here are some details you should read . . .

The FDA strongly advises consumers not to:

  • make heavy application of topical anesthetic products over large areas of skin
  • use formulations that are stronger or more concentrated than necessary
  • apply these products to irritated or broken skin
  • wrap the treated skin with plastic wrap or other dressings
  • apply heat from a heating pad to skin treated with these products.

If a health professional recommends the use of a topical anesthetic, then:

  • use a topical anesthetic that contains the lowest strength, and amount, of medication that will relieve the pain
  • apply the topical anesthetic sparingly and only to the area where pain exists or is expected to occur
  • do not apply the topical anesthetic to broken or irritated skin
  • ask your healthcare professional what side effects are possible and how to lower the chance of having life-threatening side effects from anesthetic drugs
  • be aware that wrapping or covering the skin treated with topical anesthetics with any type of material or dressing can increase the chance of serious side effects, as can applying heat to the treated area while the medication is still present
Did you learn anything new here? What are you going to do differently for yourself, or for your loved ones for safety's sake?

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Saturday, January 17, 2009

Epidemiological Reasons To Drink Alcohol For Health

As an avid wine drinker, I'm always on the lookout for reasons to justify my habit and hobby. I think most folks accept that a couple of glasses of red wine a day can be good for the heart. This American Journal of Epidemiology abstract says there are additional benefits of drinking alcohol, Light to Moderate Alcohol Consumption and Disability: Variable Benefits by Health Status. Bottomline, Moderate alcohol consumption may help seniors keep disabilities at bay reports that "light to moderate drinkers in good health had a lower risk for developing new disabilities, compared with both abstainers and heavy drinkers."

Related Posts:
Australian Wine Doctor Says Drink His Wine For Health
Wine - For Enjoyment Or Metal Ion Poisoning?!
Treat The Flu With Red Wine?!
Drug and Alcohol Interactions - Have things changed?
Drink Red Wine - Live Longer !?

P.S. I needed a new clean/dirty dishwasher magnet, and found this fun wine lover's dishwasher magnet.

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Friday, January 16, 2009

Should The FDA Oversee Nanotechnology Dietary Supplements?

If you read this Project On Emerging Nanotechnologies publication, you'll probably say yes, A Hard Pill to Swallow - Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements. Historically, the regulation of dietary supplements has been a significant challenge for the U.S. Food and Drug Administration (FDA), and the fact that some of these products are now being manufactured using nanotechnology creates an additional layer of complexity. The use of engineered nanoparticles in dietary supplements raises serious questions about whether such products are safe. Congress has generally allowed dietary supplements to be marketed without any pre-market demonstration of safety, based largely on the assumption that these products have been used for many years. There is, however, no basis for concluding that dietary supplements containing engineered nanoparticles are safe. The authors ask, "Is FDA equipped to meet the emerging regulatory challenge of dietary supplements that use engineered nanomaterials?" Here's their conclusion . . .

  • There is no basis for concluding that dietary supplements containing engineered nanoparticles are safe.
  • While it is not possible to determine the prevalence of dietary supplements containing engineered nanoparticles, it is likely that the public’s exposure to these products will grow significantly in the next several years. Congress should adopt legislation granting FDA the authority to collect additional information about these products and to ensure that they are tested for their effects on human health. Such legislation should prohibit the sale of new dietary supplements containing engineered nanoparticles until they have been demonstrated to be safe, and it should provide FDA with sufficient resources to regulate these products.
  • Until Congress acts, consumers who take dietary supplements containing engineered nanoparticles will be at additional, unknowable, and potentially serious risk.
How safe you do feel?

Related Posts:
FDA - FAQs About Combination Products

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Thursday, January 15, 2009

Go For Gold - I Mean Nanoparticles And Drugs

This just caught my eye, Team Designs Gold Nanoparticles to Deliver Multiple Drugs. This is really unusual. Build some gold nanoparticles with drugs stuck on them, and with the right infrared exposure, the gold releases the drugs. The MIT research team reports that when exposed to infrared light, the gold nanoparticles melt, releasing drug payloads attached to their surfaces. They built two different shapes of nanoparticles, called "nanobones" and "nanocapsules." Nanobones melt at light wavelengths of 1,100 nanometers, nanocapsules at 800 nanometers. The team thinks this technique could one day provide more control of diseases commonly treated with more than one drug, by attaching mulple drugs to the surface of the nanoparticles.

Very cool, don't you think?!

More Infomation:
FDA and Nanotechnology Products - FAQs

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Wednesday, January 14, 2009

FDA Draft Guidance On Good Importer Practices

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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Tuesday, January 13, 2009

Say Maaah - Goats Make Anti-Clot Drug

This could be the shape of things to come, genetically engineered animals turned drug-making machines. This LA Times article, New old-fashioned drug makers: goats, reports that genetically engineered goats produce a human protein that is extracted and turned into a medicine to fight strokes, pulmonary embolisms and other dangerous conditions caused by blood clots. A panel of the Food and Drug Administration voted overwhelmingly that the drug -- called ATryn -- is safe and effective. The FDA is expected to make a final ruling soon. If approved, this would be unprecedented, the drug would be the first from a genetically engineered animal to be approved in the United States. If ATryn gets approved, you can expect to see more milk produced by genetically engineered rabbits and cows for future lines of drugs to treat hemophilia, respiratory disease and swollen tissues.

By the way, do goats really say maaah?!

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Monday, January 12, 2009

New AHRQ Website On Emerging Issues In Medical Therapeutics

The Agency for Healthcare Research and Quality (AHRQ) announced a new educational website that offers expert perspectives, advice and guidance on drugs, biological products and medical devices from the AHRQ's Centers for Education and Research on Therapeutics (CERTs), a federally sponsored network of more than a dozen leading research centers nationwide. The new website, Clinician-Consumer Health Advisory Information Network (CHAIN) links clinicians and consumers with therapeutics information to assist in clinical practice and health care decisionmaking in areas where evidence is undergoing significant and rapid changes. This site will be of interest to manufacturers because of the touchpoints with clinicians, consumers, drugs, biologics, and medical devices, and CERT consultation and collaboration with the FDA.

What do you think about the new site? Is it useful for your purposes?

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Sunday, January 11, 2009

Abzymes Pinpoint The HIV Achilles Heel

Many thanks to Mary Ann Liebert publications (AIDS Patient Care and STDs. November 1, 2008, 22(11): 921-923. doi:10.1089/apc.2008.9938) for making the text of this HIV/AIDS and STD Update available online, "Pinpointing the Achilles Heel of HIV" (abzymes). I'm sharing this with you because this update is so well written that I'd do you an injustice in trying to rewrite it. Because there's a fair amount of interest in this topic of HIV abzymes, I'm posting this so that you can do further reading for yourself.

Related Posts:
HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video)

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Saturday, January 10, 2009

3rd Hand Tobacco Smoke - A Danger To Your Loved Ones

Tobacco smoke contamination lingers even after a cigarette is extinguished – a phenomenon defined as "third-hand" smoke, reports this Science Daily article, Third-hand Smoke: Another Reason To Quit Smoking. It's important to pay attention to this because 3rd hand smoke contains a toxic brew of gases and particles clinging to smokers’ hair and clothing, not to mention cushions and carpeting, that lingers long after smoke has cleared from a room. The residue includes heavy metals, carcinogens and even radioactive materials that young children can get on their hands and ingest, especially if they’re crawling or playing on the floor.

If you don't feel like reading the article, then watch this concise MSNBC video, 'Third-hand smoke - a new risk factor (video).'

I'm wondering if we'll see any more legislative momentum to put cigarettes and tobacco under the purview of the FDA in 2009. What do you think?

Related Posts:
FDA Authority Over Tobacco - desperately needed

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Friday, January 9, 2009

Jan Is Natl Radon Action Month - Are you safe?

Radon is a colorless, odorless, tasteless, and chemically inert radioactive gas. It is formed by the natural radioactive decay of uranium in rock, soil, and water. Naturally existing, low levels of uranium occur widely in Earth's crust. It can be found in all 50 states. Unless you test for it, there is no way of telling how much is present. If your house has high levels of radon, you need to explore ways to reduce your family's risk of lung cancer. Here are some resources you need to check out . . .

Has your house ever been tested for radon?

Related Posts:
Alert - Granite Countertops - They are HOT - Radiation and Radon Risk

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Thursday, January 8, 2009

FDA Draft Guidance On Process Validation

The FDA recently released a draft guidance for new process validation. The guidance says that manufacturers would have to increase sampling and testing, and monitor process performance more closely during the early stages of commercial manufacturing, according to the FDA's Guidance for Industry - Process Validation: General Principles and guidance. Once finalized, this guidance replaces the FDA's process validation guidance issued in 1987. The new guidance applies to pharmaceuticals, biologics and active pharmaceutical ingredients. It will cover the 3 stages of process validation — process design, process qualification and continued process verification.

Are you ready?

Related Posts:
Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending
FDA Data Guidance - When patients withdraw from clinical trials
View more FDA Guidance Documents (free)
FDA Draft Guidance On Proprietary Names
New FDA Guidance - Residual Solvents in Drug Products
New FDA Guidance - New Contrast Imaging Indication Considerations
New FDA Guidance - cGMP Practice for Phase 1 Investigational Drugs
FDA Guidance Documents - FDA Current Thinking (free)
Sign up for FDA Guidance Documents email updates.

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Wednesday, January 7, 2009

Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

The Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration, released inspection statistics for the 2007 fiscal year. The statistics for the 40 Bioresearch Monitoring (BIMO) inspections of medical device sponsors showed serious concerns for compliance with good clinical practice (GCP) regulations. Author Carl Anderson explains the CDRH findings, identifies problem areas to avoid, and gives tips on how to avoid 483s, in his article, "Trends in FDA CDRH Bioresearch Monitoring Inspections." The following are the topics he covers in the article . . .

  • About the Division of Bioresearch Monitoring Organization at CDRH
  • Medical Device Sponsor Inspections
  • Quality Systems in Clinical Trials
  • Implications of BIMO Inspection Statistics - with a top 5 category list of deficiencies

Don't get caught flat-footed. Reading this article will help you steer clear of choppy waters, warnings, and 483s.

Related Posts:
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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Tuesday, January 6, 2009

About The FDA Orange Book - Slide Deck (free)

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

- - - original post below - - -

If you use the FDA's Orange Book, or have an interest in generic drugs, exclusivity, and patents, then take a gander at this slide deck from an FDA CDER staff member, "The Orange Book (slide deck; free)." The slide deck covers . . .

  • What is the Orange Book?
  • What is exclusivity and how does it work?
  • How is the Food and Drug Administration (FDA) involved with patent protection?
Related Posts:
FDA Orange Book - Online

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Monday, January 5, 2009

Try This GMP Training Tip To Start The New Year (free)

It's time to start another annual cycle of GMP-related training efforts. Sometimes we make training more difficult for ourselves. For example, the words we choose can get in the way. In the conversations we have behind closed doors, and in public, using judging and blaming language can alienate trainees and students. Try this free training tip posted on T+D, New Year, New State of Mind, on how to apply this attitude adjustment technique.

Previous Posts:
GLP Training Tips (free)
Free GMP Training Tips - Follow adult learning principles
7 Deadly Sins Of Trainers - free tips

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Sunday, January 4, 2009

FDA Approves First New Nucleic Acid HIV Test

This just in. The FDA approved a new HIV blood test that screens for two uncommon strains of the virus recently detected in the U.S. The news release reports, FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue. This is important for a couple of reasons . . .

  • The test can simultaneously detect HIV-2 and HIV-1 Group O strains. Both types of HIV are mainly found among patients in Africa, but the FDA said they have recently been detected in the U.S.
  • It provides better protection for patients
Related Posts:
109 HIV Drugs And Vaccines Under Development
Pause And Reflect On World AIDS Day (Dec 1)
HIV AIDS Bone Marrow Transplant Cure - Skeptical View
Take The Weekend Off - That Means This HIV Med Too?!
HIV Treatment Goes Bionic
Listen To People With AIDS and HIV (audio)
HHS Updates HIV Treatment Guidelines (free pdf)
Flash - HIV Drug Treatment Needs To Start Earlier
More Than 90 Free Podcasts - International AIDS Conference 2008
Earlier Treatment of HIV Warranted in Some Patients
HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video)

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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Who Offers Live Onsite GMP Training?
Free GMP Training Tips

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Saturday, January 3, 2009

Check Out iGuard - Esp. If You Take Multiple Meds (free)

No, this isn't an Apple product or accessory. This is a free service (registration & usage are free) for folks taking medications, and offers extra benefit for those taking multiple medications, reports this BusinessWire release, One Million Americans Now Receive Personalized FDA Drug Safety Alerts Through iGuard.org. Read on for the quick highlights . . .

According to the news release, iGuard.org is different from other drug information services, because although patients today have access to an enormous set of tools for getting information about their health, iGuard.org is the only service that:

  • helps patients identify which drugs pose the greatest risk using a personalized, color-coded, drug safety rating system
  • detects potential interactions between drugs and diseases as well as interactions between drugs – recognizing that drug-disease interactions (e.g., Viagra and heart disease, birth control pills and smoking) are the highest cause of death and disability associated with medication use
  • communicates emerging product recalls (which outnumber alerts by four to one) as well as safety notifications and FDA advisories
  • avoids bombarding patients with irrelevant communications by ensuring that drug-specific messages are sent only to those users to whom they apply
  • ensures that communications are actionable and easy to understand by having a pharmacist review and update FDA / drug company alerts for the consumer audience
  • allows patients to have their doctor copied on their communications
  • is funded by medical research, not by advertising, which helps improve medicines

If you're taking meds, shouldn't you be taking advantage of iGuard?

Related Posts:
Serious Drug Interaction Risks For Older Adults (video)
MedNotes - A New Online Drug List Mgmt Tool - And More! (free)
Drug and Alcohol Interactions - Have things changed?
Deadly Overdose At Home - Especially alcohol and opioid painkillers

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Friday, January 2, 2009

FDA 510(k) Free Tips And Pearls Of Wisdom

If you're working on a 510(k) medical device submission, you might want to peek at this Medical Device Blog post that's full of great tips for avoiding heartaches, "510(k) Approval Timeline." There's some really good stuff there. Did you find those tips helpful?

If you need more info, try the FDA's own site . . .
The FDA's Information on Releasable 510(k)s:
General Information
Federal Register Notices
Search the Releasable 510(k) Database
Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered
Downloadable 510(k) Files

One gem is the FDA's "SCREENING CHECKLIST - ALL PREMARKET NOTIFICATION [510(k)] SUBMISSIONS" (free) that's used to assess whether your paperwork is complete enough or not for a substantive review.

Previous 510(k) Posts:
Medical Devices - A murky 510(k) world?!
Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending

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Thursday, January 1, 2009

Did You Pick One Of These Top 2009 New Year Resolutions?

Happy New Year!

Need a cure for a hangover? If so, then head over to 10 Tips to Treat and Prevent A Holiday Hangover.

If you chose a new year resolution for 2009, was it one of the following, reported by FranklinCovey Products' Fourth Annual New Year's Resolutions ... ? If you did choose one, I hope you picked a health-related resolution. In a nutshell, they're . . .

  1. Get out of debt or save money
  2. Lose weight
  3. Develop a healthy habit (e.g. healthy eating, exercise)
  4. Get organized
  5. Spend more time with family and friends
  6. Develop a new skill or talent
  7. Work less, play more
  8. Other
  9. Break an unhealthy habit (e.g. smoking, alcohol, overeating)
  10. Change employment

The real question is, are you going to keep your new year resolution? Live long and prosper in 2009!

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