MedlinePlus - Free Health Information from the NLM

This is a great collection of health-related information, resources, tools, and more! It's FREE!

MedlinePlus - Health Information from the National Library of Medicine

"MedlinePlus is the National Institutes of Health's Web site for patients and their families and friends. Produced by the National Library of Medicine, it brings you information about diseases, conditions, and wellness issues in language you can understand. MedlinePlus offers reliable, up-to-date health information, anytime, anywhere, for free."

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FDA Inspection - Tips by the FDAzilla Blog

A good quick primer with some useful links to resources . . .

» 20 Resources to Ace Your Next FDA Inspection FDAzilla Blog:

"FDA inspections.  If part of your job includes preparing your cGMP manufacturing facility to be ready at any second for an FDA inspection.  This page is for you.  Here are our top 20 resources and FAQs for you: . . ."

'via Blog this'


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Counterfeit Medicine - On the FDA Website

The FDA has a nice constellation of items and articles related to counterfeit medicine.

Counterfeit Medicine - US FDA Website:

"Counterfeit Medicine - Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health. 

FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation's drug supply from the threat of counterfeits."

'via Blog this'

Free information and resources about counterfeit medicine:
US FDA Website - Counterfeit Medicine

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Related articles

• Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign facilities never inspected by FDA (drughealth.blogspot.com)
• US counterfeit drug seizures up 200 per cent in 2011 (drughealth.blogspot.com)
• Surviving FDA Enforcement Actions - Free Tips (drughealth.blogspot.com)

What is GMP?

What is GMP?:

"GMP means something different when in different regions of the world."

'via Blog this'

You might also be interested in:
Essentials for Pharmaceutical Manufacturers - a SkillsPlus International Inc. a cGMP training class

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FDA CDRH Learn - CDRH Learn Spanish Language Course List

FDA CDRH Learn; CDRH Learn Course List (Spanish):    'via Blog this'

The FDA CDRH offers the following courses in Spanish:

• Overview of Regulatory Requirements: Medical Devices
 [New! 9/2]

• Quality System Regulation 21 CFR Part 820 Basic Introduction

• Export Certificates for Medical Devices

• Overview of the Premarket Notification Process - 510(k)

• Bioresearch Monitoring (BIMO)
 [New! 7/25]

• Medical Device Reporting

According to Wikipedia's Languages of the United States, approximately 10% of the US population speaks Spanish.

Hope you find these free FDA resources helpful.

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Learn From 2010 FDA Warnings To Pharma Companies

• FDA CGMP Online Training - recommended GMP online training classes offered by SkillsPlus International Inc. (a regulatory compliance training provider)

2010 is now behind us.  It's time to turn your attention to 2011. If you're in the FDA GMP training space, consider leveraging the following resource in your GMP trainings:  FDA Inspections, Compliance, Enforcement, and Criminal Investigations - Warning Letters.

From this main Warning Letters page, you can research and learn from the warning letters, that can be found by:

• Year
• Company
• Subject
• . . . and many other advanced search criteria

The Warning Letters can be used as great examples of just how important it is to comply with the regulations.

You might also be interested in:
Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

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Electronic Orange Book Online

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 - - -

The FDA offers an electronic (online) version of the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations.

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Drugs.Com - Popular and Free Pill Identifier

The internet is really something. Where else can you find free resources like this popular Drugs.com Pill Identifier?

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Another Free GXP Checklist!

• FDA GMP QSR cGMP Training. Popular online training courses by SkillsPlus Intl Inc.

Updated November 23, 2020

Link in the original post broke.

You might also be interested in:

GMP Audit Checklist For Drug Manufacturers - ISPE

- - -  original post follows below  - - -

Checkout this free checklist made available by the Auditing Group, Inc., Audit Checklist for Drug Industry.

It's another resource and perspective on approaching FDA GMP audit preparedness.

Additional Resources:
ISO 13485:2003 and FDA QSR (21 CFR 820) Internal Audit and Gap Analysis Checklist

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

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FDA Holiday Food Safety

The holidays are about spending time with friends and family. Naturally, food will be served and shared. So beware! Take a few moments to review best food handling practices to keep everybody happy and food healthy! Follow these FDA food safety recommendations, Food Safety Tips for Healthy Holidays, or download this newsletter, Food Safety Tips for Healthy Holidays (pdf). 

Bottomline...

1. Clean
2. Separate
3. Cook
4. Chill

Previous Posts: Happy Thanksgiving - Celebrate These Food Safety Tips 

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FDA Unapproved Drugs Initiative

There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Therefore, the FDA has crafted an entire suite of web pages that help manufacturers of unapproved drugs navigate the regulatory landscape, Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval. 

Here's what you can find: FDA's Concerns About Unapproved Drugs Background Information Unapproved Drugs Initiative Compliance Policy Guide Enforcement Actions Important Documents Publications Industry Information Unapproved Drug Decision Tree Unapproved Drugs Coordinator Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator Marketed Unapproved Drugs Workshop Required reporting of adverse events Health Care Professional Information Determining if a drug is FDA approved Orange Book NDC Directory http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ssLINK/ucm119742.htm#drugsatfda Legal mechanisms to access unapproved drugs Reporting of adverse events Consumer Information But best of all, they offer a FDA WebLearn Course: Bringing an Unapproved Drug into Compliance. You can get a sense of the content by scanning the companion FDA's Bringing an Unapproved Drug into Compliance - Course Script (PDF). 

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AMA Unveils Flu Assessment Tool

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Updated May 28, 2025

The original link broke.

You might also be interested in this AMA webpage:
https://www.ama-assn.org/delivering-care/public-health/influenza-virus-flu-resources

---  the original post follows below  ---

The American Medical Association (AMA) launched AMAfluhelp.org, a comprehensive Web-based patient flu health-assessment program. It walks patients through a series of questions to determine the severity of their flu symptoms based upon the latest Centers for Disease Control (CDC) and Prevention guidelines. With the influenza state of emergency with us, you can never have too many of these useful gadgets and widgets around. 

Previous Posts: FDA Search Widget of Fraudulent H1N1 Products Got Wine Flu? Flu.gov Updated by HHS - New Resources Added 

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Procedure For FDA GMP Training

Don't forget the basics! Read this classic Jim Vesper article, Defining Your GMP Training Program with a Training Procedure. Make sure you've got some well-thought out standard operating procedures that define your FDA GMP training program. 

Previous Posts: GMP Training Tree - Trainers, formats, methods, etc. Try This GMP Training Tip To Start The New Year (free) WHO Basic GMP Training Modules (free) FDA CDRH Online Courses (Free) Free WHO Training Guide To GMP Requirements Free GMP Training Tips - Follow adult learning principles Free GMP Glossary GMP Olympics - an onsite training experience 

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FDA Releases Hearing Aids Guide Online

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The Food and Drug Administration (FDA) launched a new website that benefits current and potential users of hearing aids, A New Online Guide to Hearing Aids.

The site includes sections on:

• general information on hearing aids
• types of hearing loss
• types and styles of hearing aids
• how to get a hearing aid
• benefits and safety of hearing aids
• hearing aids and cell phones
• other products and procedures that people can use to improve hearing

This is of interest to me as I grow older, and my siblings are showing signs that they might benefit from these devices.

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Got Wine Flu?

Sorry, I couldn't resist. I hope you find this amusing, What Is Wine Flu? Just in case you really wanted info on the swine flu, check out the CDC 2009 H1N1 Flu (Swine Flu) web pages. 

Previous Posts: Treat The Flu With Red Wine?! For Wine Lovers: Wine Lovers Dishwasher Magnet Champagne In The Freezer - Reminder Magnet Wine In The Freezer - Reminder Magnet (10 pack) Ask About Our Wines Magnet (10 pack) 

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Flu.gov Updated by HHS - New Resources Added

The government's Department of Health and Human Services (HHS) unveiled several new resources on the federal government's one-stop resource for flu information -- https://www.cdc.gov/flu/. Some of the new items include:

• A self-evaluation guide
• A myth and facts section

Stay well!

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Mesothelioma Awareness Day

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According to Mesothelioma Awareness Day Observed September 26 , "on September 26, 2009 those affected by the asbestos-related cancer mesothelioma and volunteers worldwide will help call attention to the rare cancer on national Mesothelioma Awareness Day. The Mesothelioma Applied Research Foundation, the non-profit organization that started the day in 2005, expects the day to be the most successful awareness day for the cancer since it was organized four years ago." 

Previous Posts: New Technique Might Help Diagnose Mesothelioma CDC Says Mesothelioma Deaths Increasing Reputable Mesothelioma Resources 

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CDC - Yellow Book for Travelers - free - online

Updated October 29, 2022

The original link broke.

Here's the latest version of the CDC Yellow Book.

---  the original post follows below  ---

When you read this, I'll be travelling. For those of you with international travel plans, you might want to check out this free online resource, the 2010 CDC Traveler's Health Yellow Book. Although this is written with the health professional in mind, anybody who's travelling can benefit from this wonderful free resource. Check it out! 

Previous Posts: Travelling This Summer? Must read tips! (CDC Traveler's Health Tips) 

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NIH NIAAA Wants Re-Thinking Drinking (video)

Take some advice from these testimonials:

• "Sometimes we do things out of habit and we don't really stop to think about it. This made me think about my choices."
• "It emphasized that drinking is not bad in and of itself—it's how much you're doing it and how it's affecting your life."
• "I thought the strategies for cutting down were really good. It gives you tools to help yourself."

Learn more about the NIH & NIAAA's new initiative to help rethink drinking, "Rethinking Drinking - Alcohol and your health. The website is pretty robust and easy to use.

• Download the free brochure: Rethinking Drinking - Alcohol and your health (pdf)
• The site features interactive tools, such as calculators for measuring alcohol calories and drink sizes. NIAAA is part of the National Institutes of Health. "About 3 in 10 U.S. adults drink at levels that elevate their risk for alcoholism, liver disease, and a diverse array of other physical, mental health, and social problems. Yet, many people give little thought to their drinking habits and the attendant risks" notes NIH Acting Director Raynard S. Kington, M.D. "These new materials remind all of us to think about how alcohol may be affecting our health"

If you don't have time to check out the website, listen to this ABC News video to learn more, "Do you drink too much? A new government initiative to help you rethink your drinking" (video)"

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Cross-Reference GLPs by FDA EPA and OECD (free)

If you ever had an interest or need to compare the GLPs (Good Laboratory Practices) across these three organizations, then you need to look at the FDA's "Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP." The information is organized in tables that cross-walk and cross-reference a particular row topic against the three columns for each organization. 

Here's what you'll be able to see:

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP - FDA.gov

Table of Contents

• Preface
• Scope and Authority
• Definitions
• Organization and Personnel
• Facilities
• Equipment
• Facility Operation
• Articles
• Protocol and Conduct
• Records and Reports
• Disqualification

Glossary: GLP = Good Laboratory Practice FDA = Food and Drug Administration EPA = Environmental Protection Agency OECD = Organisation for Economic Co-operation and Development 

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