Multivitamins Seem Benign, Maybe Beneficial

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Updated October 21, 2021

A link in the original post broke.

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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 2010 Strategic Initiatives

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Updated Dec 7, 2015:
The link in the original post went stale. You might be interested in:
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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- -  Original post follows below  - -

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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Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
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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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2010 - Border inspections and delays for device and import - more FDA presence

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Updated October 15, 2016

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What to Expect Now that the First Big FSMA Compliance Dates Are Here

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Devicemakers and importers can expect delays for inspections and screenings because the FDA is putting their trainees at US borders, reports FDAnews Device Daily Bulletin, Devicemakers May Face More Inspections, Delays in 2010:

"New employees probably will be trained at the borders because that’s where the highest volume of regulated commodities can be found"

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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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More Pharma 2010 Trends

... and even more pharma trend predictions for 2010.

Tracy Staton reports in What's the outsourcing outlook for 2010?, what we can expect in 2010 from an outsourcing perspective.

In summmary, expect:

• Outsourcing won't let up in 2010
• Outsourcing to heat-up in sales, IT, and CROs 

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Avoid The DOJ - FCPA Violations - Foreign Corrupt Practices Act

I never heard about the FCPA (Foreign Corrupt Practices Act) until reading about it today. Wikipedia says FCPA addresses accounting transparency requirements under the Securities Exchange Act of 1934 and another concerning bribery of foreign officials.

Anyways, FDANews reports that the Department of Justice’s (DOJ) FCPA and healthcare fraud units are beginning to work together to investigate FCPA violations in the device and pharmaceutical industries. The DOJ has more information about FCPA on their website.

Here's why you need to care. The DOJ wants to aggressively enforce and investigate violations of the FCPA, targeting pharmaceutical and medical device companies as well as their individual executives and board members; this leaves them open to potentially massive legal and financial liabilities.

Additional Resources:
Bribery Abroad: Lessons from the Foreign Corrupt Practices Act

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FDA Reports Another Extortion Scam by FDA Impersonators

The FDA is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

It goes something like this. The criminals call the victims (who in most cases previously purchased drugs over the Internet or via "telepharmacies") and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.  The criminals always request the money be sent by wire transfer to a designated location, usually a foreign county. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.

Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA’s Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

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Lots Of Hangover Cures To Try

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Whether you're trying to recover from the New Year celebration or not, check out these suggested cures.

I ran across this list of 17 hangover cures on Epicurious, Hangover Cures 17 helpful foods for the big-head blues.  I found it pretty entertaining, and decided I wanted to see something a little more serious.

So checkout this MSN Video, Holiday Hangover Cures, it walks through how to prevent a hangover, what to do while you're drinking, and last but not least, what to do if you get a hangover.

Cheers!

Previous Posts:
Booze Good For You in 6 Ways

For Wine Lovers:
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Booze Good For You in 6 Ways

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Updated December 9, 2021

The original link broke.

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Surprising Ways Alcohol May Be Good for You - WebMD

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This MSNBC News article, Cheers! 6 ways a little booze does the body good, gives six good reasons to rationalize your drinking habit. In summary:

1. Women who drink occasionally may live longer.
2. Moderate drinking may actually protect your brain — especially if you’re a woman.
3. Women who drink moderately are less likely to develop high blood pressure.
4. A few drinks a week might keep the heart doctor away.
5. White wine may help you breathe better.
6. Drinkers exercise more than teetotalers — and the more people drink, the more they exercise.

I'm not endorsing drinking, and thought you'd be interested in this collection of reported health benefits.