Saturday, February 28, 2009

e-Cigarettes In The News (video)

I first heard about e-Cigarettes just a few weeks ago. It's fair to say that I'm a bit fascinated by them. As a non-smoker, I can see the obvious potential benefits to me. If you've never heard of them before, read this Fox News article: Chinese E-Cigs Rapidly Gaining Ground Amid Health Concerns, or view this news video on Metacafe:

E-Cigarette Electronic Cigarette E-Cig In The News - The best bloopers are a click away

Do you think e-cigarettes are a good idea?

Related Posts
Fire Safe Cigarettes Are A Good Thing
3rd Hand Tobacco Smoke - A Danger To Your Loved Ones
Menthol in Cigarettes - Cig makers might've played you! (video)

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Friday, February 27, 2009

Global Outsourcing - Clinical Drug Trials - Hot Debate

Global outsourcing continues, and fuels some interesting debate, as evidenced by this recent New England Journal of Medicine (NEJM) article, "Ethical and Scientific Implications of the Globalization of Clinical Research." Of current interest, one of the author's name, Robert Califf, comes up as a candidate to lead the FDA.

In CenterWatch's Clinicial Trials Today post, "Duke, NEJM Study Renews Debate on Global Outsourcing, they say "the NEJM study findings support common criticisms that trial participants in developing countries are often less informed and unduly influenced by the promise of money or medical care in return for participating in a study. While critics of clinical research in emerging areas (comprising 16% of total global clinical trials) can deride the informed consent process there, the West is no stranger to these problems."

Related Posts:
FDA Draft Guidance - Drug Supply Chain and SNIs
FDA - Global Drug Supply Chain Needs Better Oversight
Prescription Drug Reimportation and Safety - Both Presidential Candidates Support It

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Wednesday, February 25, 2009

Foreign Pharma Inspection Trends - Burdensome

"In today's global marketplace, a single manufacturing site may supply more than 80 markets and spend as many as 137 days working on one inspection, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA)," reports this PharmTech.com article, Trends In: Foreign Inspections. It turns out that the most active inspectorates in order of activity reported are those from the European Union, United States, Brazil, Japan, Mexico, South Korea, and Uganda.

Are foreign inspections eating your lunch?! If so, how can we transform current practice into a better solution to assuring compliance? Perhaps joint inspections?!

Related Posts:
FDA Draft Guidance - Drug Supply Chain and SNIs
FDA - Global Drug Supply Chain Needs Better Oversight
Prescription Drug Reimportation and Safety - Both Presidential Candidates Support It

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Monday, February 23, 2009

Easy FDA Orange Book Search Widget

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)


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 - - -

You can perform your FDA Orange Book searches on the FDA's site, or you can use this Search Orange Book Widget to conduct your searches using a single interface. No more switching back and forth between multiple web pages! I used the widget as is, at the link location above. Some of you more tech savvy folks might consider installing the widget. Here's what the widget creator says . . .

by viswanathaa
Created 10/28/08
With all search options conveniently under one window, this widget allows one to search the US FDA electronic orange book faster & from your own homepage.

Happy hunting!

Related Posts:
FDA Orange Book - Online
About The FDA Orange Book - Slide Deck (free)

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Saturday, February 21, 2009

Court Says MMR Vaccine Not A Cause of Autism (video)

A special court's recent ruling that no proven link exists between autism and certain early childhood vaccines seems to have done little to change the sometimes-passionate opinion fueling the debate. The panel of "special masters" ruled that these petitioners had not presented sufficient evidence to prove that the childhood vaccines (specifically the measles-mumps-rubella vaccine containing thimerosal, a mercury-based preservative) caused autism in their children. Learn more about this court ruling in this ABC News Video report, WATCH: Ruling on Autism and Vaccines.

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Friday, February 20, 2009

How About A Side Of Acrylamide With Your Fries or Chips?

Updated May 24, 2016  - the original post had tons of broken links.

The FDA has had a long history of monitoring acrylamide in our diet. Acrylamide can be formed in various heat-treated, carbohydrate-rich foods. Particularly high concentrations of acrylamide can be found in potato chips, breakfast cereals, and crisp bread. It's thought that eating food products containing acrylamide might constitute a potential risk to human health. This recent study, Chronic intake of potato chips in humans increases the production of reactive oxygen radicals by leukocytes and increases plasma C-reactive protein: a pilot study suggests that acrylamide from foods may increase the risk of heart disease, reports this Medical News Today article, Study Provides Additional Evidence That Potato Chips Should Be Eaten In Moderation.

I'm not going to stop eating potato chips or fries. And I will try to avoid eating too much of them. Will this information change your diet?

Additional FDA Information:
FDA Acrylamide webpage
FDA - Acrylamide Q and A
FDA - You Can Help Cut Acrylamide in Your Diet

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Wednesday, February 18, 2009

FDA - Proposed Regulatory Changes For SUDs

The FDA has submitted the following proposed collection of information to OMB for review and clearance: Guidance for Industry and Food and Drug Administration Staff; Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly ``Reprocessed Single-Use Device Labeling'') (Federal Food, Drug and Cosmetic Act, Section 502(u)) (OMB Control Number 0910-0577) -- Extension. This is about requiring devices (both new and reprocessed) to bear prominently and conspicuously, the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer.

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Monday, February 16, 2009

New FDA Genomics Position Announced

I'm glad to see this, as reported by Medscape Medical News, FDA Creates New Genomics Position. With burgeoning scientific advances in this area, it's great to see the FDA attempting to stay caught up with the rest of the industry sector. I remain hopeful of the FDA doing the right things, and am happy to see them being appropriately influenced, as evidenced by this quote . . .

Dr. Torti said, "The FDA's emphasis on a coordinated genomics effort is the outcome of the June 2008 FDA Symposium and Retreat on Genomics, the recommendations of FDA's advisory Science Board, and our own internal planning."

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Saturday, February 14, 2009

Swill Coffee To Lower Dementia Risk

Drink coffee and reduce your risk of developing dementia, reports this New York Times article, Coffee Linked to Lower Dementia Risk. The article talks about recent research that found out that the subjects who had reported drinking three to five cups of coffee daily were 65 percent less likely to have developed dementia, compared with those who drank two cups or less.

As a coffee and green tea drinker, I'll have to make sure I drink that extra cup or two of coffee for myself (since my habit is to usually start with one cup of coffee, then transition to green tea).

Related Posts:
Caffeine - Overdose? It's in lots of drinks! (video)

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HIV AIDS - Gene Research Shows Promise

Jay Levy of UCSF wrote a recent editorial in the NEJM (Levy, NEJM, 2/12/09), as reported in this Medical News Today article, New HIV/AIDS Research Directions Show Promise, NEJM Editorial Says. This is the first time I've read about this, and find it incredibly fascinating and exciting. Here are my takeaways from reading the article . . .

  1. Recent HIV/AIDS research that examines the role certain genes play in inhibiting HIV progression shows promise for the development of new treatment measures
  2. HIV enters the body through CD4+ T cells and then binds to the chemokine receptors CCR5 and CXCR4.
  3. Research has found that people whose cells lack expression of the CCR5 gene typically demonstrate resistance to the virus.
  4. Researchers examined the case of an HIV-positive patient with myelogenous leukemia who received a bone marrow transplant from a person whose cells lacked expression of the CCR5 gene. After two transplants, the researchers determined that the patient had no leukemia recurrence and no detectable level of HIV in the bloodstream
  5. Levy says, "the result of this study [reported in the same NEJM issue] and others provide further encouragement for those examining approaches to treatment that reduce CCR5 [receptor] expression in persons with HIV." This is the study Levy refers to, Brief Report: Long-Term Control of HIV by CCR5 Delta32/Delta32 Stem-Cell Transplantation (summary).

Related Posts:
CDC Adopts 2 New HIV Intervention Approaches
HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword
Abzymes Pinpoint The HIV Achilles Heel
109 HIV Drugs And Vaccines Under Development
HIV AIDS Bone Marrow Transplant Cure - Skeptical View
HIV Treatment Goes Bionic
HHS Updates HIV Treatment Guidelines (free pdf)

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Friday, February 13, 2009

Citizen Petition Asks FDA To Ban Wheat Gluten In Medicines

If you have celiac disease, or some other gluten intolerance or allergies, you'll be interested in this post, Citizen's Petition to the Food and Drug Administration (FDA) to Make Drugs Gluten-Free. I have an interest in this petition because one of my family members has an allergy to gluten that results in severe skin eruptions.

You can read the petitioner's submission and the FDA's response here . . .
Regulations.gov search for 2008-P-0333 - contains the thread between petitioner & FDA
The petitioner's submission (pdf)

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Wednesday, February 11, 2009

FDA Reports Latest List of Potentially Risky Drugs

The FDA has just released its quarterly Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008. The FDA has identified potential safety issues, but this does not mean that FDA has identified a causal relationship between the drug and the listed risk. I've listed the July - Sept '08 list of affected drugs here . . .

Product Name: Active Ingredient (Trade) or Product Class (Potential Signal of Serious Risk/New Safety Information)

  1. Codeine-containing cough medicine (Adverse events in children)
  2. Oral bisphosphonates (Esophageal cancer)
  3. Mefloquine HCl (Lariam)(Psychiatric events)
  4. Minocycline (Thyroid disorders)
  5. Bupivicaine intraarticular injection given by infusion pump (Chondrolysis)
  6. Selective serotonin and selective norepinephrine reuptake Inhibitors (SSRI and SNRI) antidepressants (Birth defects)
  7. Propylthiouracil and Methimazole (Hepatotoxicity)
  8. Phenytoin injection (Cardiac arrest due to rapid injectionK)
  9. Terbinafine (Lamisil) oral use (Psychiatric events)

For more complete FDA information:
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
Quarterly Reports
2008 January to March
2008 April to June
2008 July to September

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Tuesday, February 10, 2009

FDA and SAEC Release First Data on Genetic Basis of ADEs

The FDA just announced, FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events. The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions.

“We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” said Arthur Holden, founder and chairman of the SAEC.

This is a pretty exciting example of how to apply genomics to research the genetic basis of serious adverse events.

Additional Information:
For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org.
For information on the FDA’s Critical Path Initiative see http://www.fda.gov/oc/initiatives/criticalpath/

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Monday, February 9, 2009

No Escape For Pharma Contract Mfg Orgs - CMOs

Patricia Van Arnum reports in her PharmTech Talk article, Contract Manufacturers: Watch Out for a Bumpy Ride, "the troubling conditions of the US economy as a whole and the resulting curtailment in financing and credit was hurting an important customer base for CMOs: emerging pharmaceutical companies." As I see it, the economy continues to crater, and there doesn't seem to be any particular industry sector immune to the current state of the economy. Although the stats cited in the article indicate otherwise, as a stock holder of some pharma stocks, I remain hopeful and optimistic for a rapid economic recovery.

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Saturday, February 7, 2009

Fire Safe Cigarettes Are A Good Thing

I've not heard about fire-safe cigarettes until now, after reading this MSNBC News article, Smokers burned up over ‘fire-safe cigarettes’ - Self-extinguishing smokes sweep the country, but many say they taste bad. As a non-smoker, I think they're a good idea. Living in a parched, drought-stricken location, I see far too many lit cigarettes tossed on the ground, posing a potential fire danger. I can also see the benefit to those choosing to smoke in bed, or prone to falling asleep while smoking. I can see why it'll be hard for remaining states to resist the tide to enact fire-safe cigarette laws.

Additional Resources:
Coalition for Fire-Safe Cigarettes
Petition to repeal fire-safe cigarette laws

Related Posts:
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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Friday, February 6, 2009

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

Wednesday, February 4, 2009

FDA Video Reassures Consumers - Peanut Products

Updated May 24, 2016 - The original video link broke. I've replaced it with something that might still interest you.

The U.S. Food and Drug Administration (FDA) wants to be clear with consumers as to what is safe and what should be avoided when it comes to peanuts and peanut products. David W.K. Acheson, M.D., Associate Commissioner for Foods at the U.S. Food and Drug Administration, talks about the current peanut butter recall and offers viewers a reassuring message about how to be careful with peanut products, in this FDA Responds to Peanut Butter Recall (video):

The replacement video comes from this FDA webpage, FDA - Food Allergies: What You Need to Know





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Monday, February 2, 2009

ASQ Announces Certification Exam For GMP Professionals

Updated May 24, 2016 - Old links just don't age well. I've made some edits.

PharmTech reports, New GMP Professional Exam Offered. It's great to see the bar getting raised with the proliferation of GMP certifications. It's nice to see the American Society for Quality (ASQ) jump into the fray by offering a certification exam based on their understanding of the body of knowledge (BOK) deemed necessary for GMP pros.

There are various degrees of rigor in GMP certifications being offered out there. Where do you think this will fit into the certification scene?

For more information:
ASQ Training & Certification
ASQ - The Value of an ASQ Certification

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