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."
"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?!
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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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.
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.
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."
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).
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 . . .
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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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)
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)
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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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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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
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.
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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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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Listen to what the CDC is thinking by listening to these podcasts in English or Spanish
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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