Multivitamins Seem Benign, Maybe Beneficial

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Updated October 21, 2021

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Information for Consumers on Using Dietary Supplements - FDA.gov

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We might never really know for sure in my lifetime. I take them because I think my diet isn't diverse enough.

In any event, here's an interesting read published by the Washington Post, Evidence is thin that multivitamins are beneficial, but they seem benign. 

Learn more about vitamins:
- in this FDA video, Fortify Your Knowledge About Vitamins (video)
- read this book, The Complete Idiot's Guide to Vitamins and Minerals, 3rd Edition

Do you take them? ... and why?

#FDA #GMP #training #cGMP

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FDA CDRH Announces Strategic Initiatives

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Updated Dec 7, 2015:
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FDA CDRH Strategic Priorities and Updates

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There's a lot here. I recommend you view this or download the FDA PDF, CDRH FY 2010 Strategic Priorities.

Here's what you'll find:

Executive Summary
Priority 1. Fully Implement a Total Product Life Cycle Approach
Strategy 1.1. Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions
Strategy 1.2. Improve Guidance and Regulation Development
Strategy 1.3. Develop a Cross-Center Compliance Strategy
Priority 2. Enhance Communication and Transparency
Strategy 2.1. Develop a Strategic Approach to Public Communication
Strategy 2.2. Improve Internal Communications
Strategy 2.3. Increase Transparency in Decision Making
Priority 3. Strengthen Our Workforce and Workplace
Strategy 3.1. Recruit, Develop, and Retain High-Quality Employees
Strategy 3.2. Leverage External Expertise
Strategy 3.3. Establish Pathways for Resolving Differences of Opinion
Strategy 3.4. Improve Internal Administrative Processes
Strategy 3.5. Make CDRH's White Oak Facilities More Workplace-Friendly
Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs
Strategy 4.1. Foster Development of Medical Devices to Respond to Unmet Public Health Needs
Strategy 4.2. Develop a Personalized Medicine Program

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Pharmaceutical Manufacturing Handbook - Regulations and Quality - free online book

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Updated Jan 1, 2016:

The post below didn't age well.  The free online book is no longer available.
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Checkout this free online book by Shayne Cox Gad:

Pharmaceutical Manufacturing Handbook - Regulations and Quality

Here's what's inside the book:

• Section 1:  Good manufacturing practices (GMP)
• Section 2:  International regulation of good manufacturing practices
• Section 3:  Quality
• Section 4:  Process analytical technology (PAT)
• Section 5:  Personnel
• Section 6:  Contamination and contamination control
• Section 7:  Drug stability
• Section 8:  Validation

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FDA Says Watch Out For Fake Alli Capsules

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The U.S. Food and Drug Administration (FDA) is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).  The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

• Outer cardboard packaging missing a “Lot” code;
• Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
• Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Related Posts:
Counterfeits In The Global Drug Supply

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Counterfeits In The Global Drug Supply

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More bad news about fake drugs getting into the global drug supply.  This Chemical and Engineering News article is very well written, Fake Pharmaceuticals - Those fighting against counterfeit medicines face increasingly sophisticated adversaries.

Here are my takeaways:

• "The best “guesstimate” is that 1% of drugs in the developed world are counterfeit. In developing nations, between 10 and 50% of drugs are thought to be fake."
• "Is it possible to stop medicines counterfeiting altogether? I doubt very much whether it is. All we can do is to try our best to secure the supply chain."

Related Reading:
Making a Killing: The Deadly Implications of the Counterfeit Drug Trade

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