FDA Guidance On ICH Q8-10

This FDA guidance, FDA - Guidance for Industry - Q8, Q9, and Q10 - Questions and Answers, reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.

The guidance, in Q & A format covers:

• Q8 (R2) Pharmaceutical Development (includes the Q8 parent guidance (Part I) and the annex (Part II), which provides further clarification of the Q8 parent guidance and describes the principles of quality by design)
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality Systems

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World No Tobacco Day is May 31st 2010

If you're a smoker, consider trying to stop smoking on World No Tobacco Day.

On the 31st of May each year, WHO celebrates World No Tobacco Day, highlighting the health risks associated with tobacco use and advocating for effective policies to reduce consumption. Tobacco use is the second cause of death globally (after hypertension) and is currently responsible for killing one in 10 adults worldwide.

The theme of World No Tobacco Day 2010 is "Gender and Tobacco" with an emphasis on marketing to women. The campaign focuses on the damaging effects of tobacco marketing towards women and girls.

The World Health Organization (WHO) urges governments and the public:

1. to demand a ban on all forms of tobacco advertising, promotion and sponsorship
2. to support implementation and strong enforcement of legislation to provide 100% protection from tobacco smoke in all public and work places, and
3. to take global action to advocate for women's freedom from tobacco.

The World No Tobacco Website
 
Previous Posts:
Tobacco Products - Big Pharma Takes On Big Tobacco
FDA Restricts Cigarette and Tobacco Sales and Distribution
Tobacco Will Kill Millions Next Year
FDA Launches New Tobacco Products Center
 
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Global Drug Supply - Counterfeit Drug Debate Heats Up

One would think that it should be fairly straightforward to drive fake and counterfeit drugs out of the global drug supply chain. It turns out there are polarized viewpoints and specific interests by many involved, as reported by SecuringPharma, Counterfeit drug debate heats up at World Health Assembly.

The situation boils down to, some:

". . . countries disagree with the WHO's working definition of the term 'counterfeit', which they maintain is being confused with intellectual property rights (IPR) issues, preferring instead terms such as 'falsely labelled', 'spurious' and 'substandard'."

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• What are Fake Drugs? Counterfeit Medicines Dangers, Side Effects (healthhype.com)
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FDA Draft Guidance - Medical Device ISO - Voluntary Audit Report Submission Program

The Federal Register notice just announced the availability of the FDA Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.

The medical device ISO 13485:2003 Voluntary Audit Report Submission Program outlined in this draft guidance is another way in which FDA may leverage audits performed by other Global Harmonization Task Force (GHTF) regulators and accredited third parties in order to assist the agency in setting risk-based inspectional priorities.

The FDA recommends that a domestic or foreign device manufacturer that is subject to the requirements in 21 CFR Part 820, Quality System (QS) regulation be eligible to participate in the ISO 13485:2003 Voluntary Audit Report Submission Program under certain circumstances described on the FDA webpage (link provided above).

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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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FDA Focus On Contact Lens Use And Safety - Medical Device

Approximately 30 million U.S. contact lens wearers use a variety of lens care products available in most pharmacies. Improper care of contact lenses can lead to a variety of eye infections. Over the past few years the FDA has been working to reduce risks of eye infections.

The FDA reinforces the latest thinking in its post, Looking Good: Safe Use and Care of Contact Lenses (May 2010).

For even more information, go to the webpage, FDA Contact Lenses.

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FDA Compliance Manual For Dietary Supplements

The FDA recently made the following available online, Dietary Supplements, Import and Domestic - Ch 21 Food Composition, Standards, Labeling, and Economics - Food and Drug Administration (FDA) - Compliance Program Guidance Manual.

It's a great reference that should be reviewed by everybody in the dietary supplement sector. Of note:

1. Part III - Inspectional - a wonderful listing of things to pay attention to, in almost checklist fashion
2. Part V-A - GMP Violations - watch out! Don't commit any of these major deviations:

• Lack of master manufacturing records or significant requirements not included
• Lack of finished product release criteria or failure to test (all or subset of finished batches) or meet finished product release criteria critical to product safety and quality
• For significant dietary ingredients, e.g. those that make up the bulk of the product, failure to establish specifications for incoming material or failure to conduct identity testing
• No quality control review procedures or significant quality control procedures not implemented
• No batch records
• Significant physical plant deficiencies.

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IFPMA Launches 10 Principles On Counterfeit Medicines

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) hopes the The IFPMA Ten Principles on Counterfeit Medicines will highlight the full scope of the problem and demonstrate that the fight against counterfeit medicines is simply about protecting patients’ health.

In a nutshell, here are the 10 principles:

1. Medicine counterfeiting is first and foremost a crime against patients
2. Counterfeit medicines threaten the full spectrum of legitimate medicines.
3. Patents have nothing to do with counterfeiting and counterfeiting has nothing to do with patents.
4. All substandards are not counterfeits.
5. A medicine that is authorized for marketing by one regulatory authority but not by another should not be regarded as counterfeit.
6. Government regulatory and enforcement authorities must be fully vested with the proper power and adequately resourced to fight counterfeits.
7. Stopping the international trade in counterfeit medicines is vital.
8. All stakeholders across the pharmaceutical supply chain must be made aware of the health threats posed by counterfeit medicines and collaborate.
9. Global cooperation is needed
10. The leadership of the World Health Organization (WHO) is crucial.

More Information:
IFPMA launches Ten Principles on Counterfeit Medicines - News Release

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FDA Issues Dietary Supplement Warning Letter

Here we go folks. It appears we're going to start seeing action by the FDA in the Dietary Supplements sector.

This FDA Law Blog post reports the issuance of an FDA warning letter, FDA Posts its First Dietary Supplement GMP Warning Letter.  A nice read.

If you want to see what else is going on, go to the FDA's Electronic Reading Room - Warning Letters - Browse Warning Letters By Subject - the letter D - scroll down to the Dietary Supplement selections.

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FDA Orders Baxter Colleague Infusion Pump Recall and Destruction

Checkout this post on the Designated Representative and Exemptee Blog, FDA Orders Recall and Destruction of Baxter Colleague Infusion Pumps.

It turns out after multiple attempts by Baxter to fix many pump problems, the FDA has had to come down hard by ordering the recall and destruction of the Colleague infusion pump.

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FDA Wants Companies To Prevent Cargo Theft

The FDA is committed to protecting consumers from the threat of stolen, counterfeit, and diverted FDA-regulated products such as prescription or over-the-counter medicines, medical devices, or infant formula.

The U.S. Food and Drug Administration sent a letter (FDA Urges Industry to Take Additional Steps to Prevent Cargo Theft),  to companies and a wide range of other key stakeholders detailing the agency’s concern over cargo and warehouse thefts of FDA-regulated products.  In its letter, the FDA seeks to:

1. raise awareness among industry about each firm’s responsibility to review and strengthen their security practices
2. inform industry of the actions the FDA will take when the agency becomes aware of a large-scale theft, and outlines steps that firms should take
3. emphasize the importance of notifying and informing members of the supply chain and the public after thefts occur.

The FDA believes every company should have a clear plan developed on how to respond to these incidents, since swift action is essential. The agency believes prevention of cargo theft is critical. To help achieve that goal, the FDA will continue to work closely with manufacturers and wholesalers to find ways to better secure the nation’s supply chain, which protects the public health.

Additional FDA Resources:
The FDA Cargo Thefts Webpage - FDA created this webpage to provide timely notice to the public about cargo thefts involving FDA-regulated products that have been stolen either from warehouses or tractor-trailers.

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