Knock, Knock, FDA Calling

This is a nice article with a nutritional supplement twist to it.

Knock, Knock, FDA Calling - Slowtwitch.com:

"In the United States, the Food and Drug Administration (FDA) is responsible for protecting and promoting public health with ultimate oversight of food and drugs, and of particular interest for this article, the nutritional supplement industry. Their regulatory control covers two main areas: product safety and accurate product labeling. This article summarizes some of what goes on behind the scenes to keep consumer products safer."

'via Blog this'

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Tobacco Products - Big Pharma Takes On Big Tobacco

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This is an interesting battle that's emerging, according to Timothy Carney in his article, Big Pharma rumbles with Big Tobacco on products.

The viewpoint provides a good grounding of the tobacco product landscape, and the emerging industry heavyweights positioning to do battle for government influence and ultimately consumer dollars.

Who's going to win?

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Electronic Cigarettes - Update - Ruling Stops FDA From Blocking Importation

A federal judge says the FDA (Food and Drug Administration) overstepped its authority in efforts to regulate electronic cigarettes, reports this Washington Post article, FDA can't block importing of 'electronic cigarettes'.

The FDA's position:
FDA says they've found cancer-causing ingredients in the products, despite manufacturers’ claims that they are safer than tobacco cigarettes.

The judge's position:
Electronic cigarettes are “the functional equivalent of traditional cigarettes."

Bottomline:
U.S. District Judge Richard J. Leon determined that electronic cigarettes are tobacco products and are not subject to restrictions.

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GMP Training - The end is near - I mean 2009!

Yep, the year is coming to a close. If 2009 snuck up on you and you still have some training needs, it's not too late. Arranging some onsite training might be challenging, but it's not too late to identify vendors that offer products and services that you can leverage. For example, buy some modules or materials, so that you can deliver training yourself. Or, locate vendors that offer online delivery of training via CBT (computer based training), so that you don't have to spend an arm and a leg to bring in a trainer on-site. The fastest way to find vendors who can help you, is to use www.google.com and search on "gmp training". 2009 is almost gone, and it's time to start planning your 2010 regulatory training plan. 

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FDA Search Widget of Fraudulent H1N1 Products

• Respected FDA cGMP online training courses and programs taught by SkillsPlus International Inc.

Updated March 10, 2022

The original links are no longer available.

You might also be interested in:

Protect Your Family From Fraudulent Flu Products - FDA.gov

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H1N1 Fraudulent Products

This FDA widget helps you find out if a product you're interested in is legitimate or a fake.
I commute on public transportation every day. We're in the height of cold and flu season. I'm not likely to try any of these products, but if you're interested, check them out before you buy them. Let the buyer beware!

Launch FDA widget:
H1N1 Fraudulent Products

Previous Posts:
Got Wine Flu?
Flu.gov Updated by HHS - New Resources Added
FDA Posts Current Flu Info and Resources
Swine Flu Increases Demand For Masks (video)
Treat The Flu With Red Wine?!

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FDA Releases Proposed Guidance On Combination Products

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Updated July 5, 2024:

Links broke in the original post.

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FDA - Combination Products Guidance Documents

- - -  original post follows below  - - -

This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice Requirements for Combination Products (pdf). According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.

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IATA Perishable Cargo Regulations Take Effect

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Updated Jan 18, 2017:

The original post contains many invalid links.

You might still be interested in:
IATA Perishable Cargo Regulations
IATA Time & Temperature Sensitive Labels

= =  original post follows below  = =

Kevin O'Donnell reminds us that the new version of IATA's Perishable Cargo Regulations (PCR) take effect on July 1, 2009, in one of his recent Where Cooler Heads Prevails Blog (http://www.coolerheadsblog.com/) posts, Links to IATA's New Regulations for Time and Temperature-Sensitive Healthcare Products.

In one of his earlier posts, New IATA Regulations Take Effect July 1st, 2009, he writes, "The International Air Transport Association (IATA) will release the 9th Edition of the Perishable Cargo Regulations in June, with the content effective July 1st, 2009. Commonly referred to as Chapter 17, (Air Transport Logistics for Time- and Temperature-Sensitive Healthcare Products), it has undergone considerable revision and represents the airline's pro-active effort to improve handling processes for high-value, high-volume healthcare cargo, including requirements for implementation of a new handling label."

In a nutshell, the 9th edition of the PCR introduces new requirements for the transportation logistics of healthcare products. Amongst these are a new quality management system, training requirements and a new label (mandatory as of July 2010). These changes are the result of the collaboration by carriers with pharmaceutical associations and many other stakeholders in the supply chain, all within a major revision to Chapter 17.

Additional Resources and Materials:
The new IATA “Time and Temperature Sensitive” label and training requirements
The IATA Perishable Cargo Regulations manual

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Free Intro To Biomedical Engineering (videos)

Updated August 26, 2024

The structure of the Academic Earth site has changed.

You can find many of the mentioned classes, through their search function.

Here's one search, using "biomedical engineering" to get you started:

https://academicearth.org/?s=biomedical+engineering

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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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FDA Collaborates On Nanotech Initiative

The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. I'm glad to see this. Until nanotechnologies are better and more deeply understood, it makes sense to me that the best minds thinking about nanotech are collaborating. More FDA Information: FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative - Overarching goal: developing an efficient pathway for safe and effective nanoengineered medical products 

Related Posts: Should The FDA Oversee Nanotechnology Dietary Supplements? Go For Gold - I Mean Nanoparticles And Drugs FDA - FAQs About Combination Products 

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FDA Warning On Weight Loss Products

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Updated December 28, 2021

The links in the original post broke.

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Tainted Weight Loss Products - FDA.gov

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No doubt we'll have overeaten on Christmas, and we'll continue to do so through the holidays. Then in the new year, we'll all be tempted to lose some weight. We'll schedule workouts at the gym, go on diets, and start taking weight loss products. But stop and read before you take those weight loss products, warns the FDA, as reported in a recent American Society of Health-System Pharmacists (ASHP) daily news briefing. In general, the FDA "has listed more than 25 weight loss products to avoid, because they contain ingredients that are not labeled, and could cause serious health problems." Some of the ingredients illegally contain drugs that should be sold by prescription only. The news briefing suggests the following links for further reading . . . Are you planning to take weight loss pills? 

Bloomberg News - Illegal Weight Loss Pills May Cause Heart Attacks 

FDA News - FDA Warns Consumers About Tainted Weight Loss Pills 

AP News - FDA warns against some diet pills sold on the Web 

HealthDay - FDA Warns About Weight Loss Products 

Chicago Tribune - FDA warnings for 30 diet drugs 

WebMD - FDA Warns of Risky Weight Loss Pills 

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Interesting FDA History - CFR for white chocolate

Updated October 3, 2016

Some of the links in the original post below have broken.

You might also be interested in:
Guidance for Industry: Standard of Identity for White Chocolate - FDA

- -  original past follows below  - -

This is something fun to read on Christmas day. Many years ago, chocolate manufacturers had to fight for the ability to use the term "white chocolate," as this Chocolate.com article recounts, "White Chocolate FDA Standard." If you didn't already know, the FDA has very specific specifications for what qualifies as white chocolate, "PART 163 -- CACAO PRODUCTS -
Subpart B--Requirements for Specific Standardized Cacao Products - Sec. 163.124 White chocolate.

Merry Christmas!

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FDA - FAQs About Combination Products

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If you're just getting into the regulations that govern combination products, or need a quick refresher, then check out this collection of FDA Frequently Asked Questions about combination products, published by the FDA. 

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The FDA On Combination Products (drug-biologic with medical device)

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Updated June 30, 2021

The original link broke.

You can read more about the topic here:

Frequently Asked Questions About Combination Products - FDA.gov

---  the original post follows below  ---

It's hard enough to comply with a single set of regulations. Now it's even harder, if you manufacture a combination product (which has a drug/biologic component and a medical device component). That's because a larger set of rules and regulations have to be followed, says this PharmTech Talk article, "Combo Products Come with More Regs." 

Bottomline, you can expect an increase in "GMP regulatory action along both the laboratory and manufacturing lines." 

Previous Posts: 

Nice Review of US FDA Medical Device Regulation 

Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

FDA Guidance Documents - FDA Current Thinking (free) 

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