Yellow Book Home | Travelers' Health | CDC

Updated September 2, 2024

The original link broke.

You can still access the same Yellow Book resource here:

https://wwwnc.cdc.gov/travel/page/yellowbook-home

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2014 Yellow Book Home | Travelers' Health | CDC:

"Explore Travel Health with the new 2014 Yellow Book!

CDC Health Information for International Travel (commonly called the Yellow Book) is published every two years by CDC as a reference for those who advise international travelers about health risks. The Yellow Book is written primarily for health professionals, although others will find it useful."

Follow this link to the CDC Yellow Book (online)

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The Exemptee Institute
The Designated Representative Institute

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2013 FDA Orange Book - New!

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

- -  original post follows below  - -

FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (pdf) has just been posted on the FDA's website.

It's the 33rd edition.

It lists products that have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume is current through December 31, 2012.

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The Exemptee Institute
The Designated Representative Institute

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Bad Pharma - Book Review

• FDA CGMP Online Training. Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses | Provided by SkillsPlus International Inc.

No doubt this will be a provocative read.  Follow the link to a comprehensive review of the book.

Science-Based Medicine » Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry:

"Closing thoughts
This is a book with important messages for patients, health care professionals, governments, and the pharmaceutical industry. It may anger, and even infuriate you. It should. Yet Goldacre sketches out a path for reform – one in which transparency is the rule, not the exception, and one in which the pharmaceutical industry can engage with the health care system in ways that will help it do what we all want it to do – bring innovative new medications to market that improve the health and welfare of patients. This change, however, will only come when we demand better – better from pharmaceutical companies, better from regulators, and better from our fellow health professionals. Ultimately, we’ll have the industry we deserve – if we’re not willing to demand better, we’re never going to see any improvements. This book is your call to action."

'via Blog this'

Order the book through Amazon.com:
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Kindle Edition)

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It's Here! 2012 FDA Orange Book!

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

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It finally arrived!

The FDA Orange Book for 2012 (32nd Edition)  has just been posted. It's current through Dec 31, 2011.

It's also posted in this location:
FDA - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Publications

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Related articles

• Electronic Orange Book Online - It'll be a wait for the 2012 version (drughealth.blogspot.com)

Electronic Orange Book Online - It'll be a wait for the 2012 version

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 - - -

Electronic Orange Book Online | The Health, Drug, Prescription, and GMP Supersite:  'via Blog this'

OK you eager beavers out there!   If history serves us, you'll have to wait until the end of Q1 2012 to see a brand new cumulative version of the Orange Book that is current through the end of 2011.

In the meantime, just navigate to the link provided above for your needs.

Happy hunting, and be patient!

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FDA Orange Book - New - Updated For 2011

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)


You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

There's been a lot of interest in the FDA's Orange Book by readers. Therefore, I'm pushing this information out to folks, so that they're aware.

It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.

If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Happy hunting!

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FDA Orange Book 2011 - It Just Arrived!

Updated April 16, 2019:
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 - - -

I've been watching and waiting for this to be released.

It's here, the FDA's Orange Book 2011 - Approved Drug Products With Therapeutic Equivalence Evaluations 31st Edition (PDF). This volume is current through December 31, 2010.

If you want to search the Orange Book in other ways, go to the FDA's webpage, FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Happy hunting!

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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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FDA Orange Book - Most Current Versions

• People speak highly of this FDA CGMP Online Training - trusted FDA GMP online training courses offered by SkillsPlus International Inc.

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 follows below - - -

The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.

You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more,  for this publication that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.

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New - FDA Orange Book

• Trusted FDA GMP online training programs and courses by SkillsPlus Intl Inc.

Updated May 26, 2022

The original link broke. You might also be interested in:

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations - a webpage

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It's here! The February 2010 supplement of the FDA's Orange Book, APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS - 30th EDITION - Cumulative Supplement 02 - February 2010 (pdf).

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Brand New! FDA 2013 Orange Book 33rd Edition (pdf)

Updated March 3, 2020:

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

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New! - The 2010 FDA Approved Drug Products with Therapeutic Equivalence Evaluations 30th Edition (also known as the Orange Book).

Complete! - This FDA Orange Book 30th Edition is current through December 31, 2009.

Learn more about the Orange Book on the FDA website - Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).

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Multivitamins Seem Benign, Maybe Beneficial

Image via Wikipedia

• Trusted FDA CGMP online training courses and programs by SkillsPlus International Inc.

Updated October 21, 2021

A link in the original post broke.

You might also be interested in:

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 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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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.

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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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FDA GMP - Tips on Penicillin Drugs

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

- -  original post follows below  - -
Here's a little refresher in the form of 4 questions, answered by the FDA, Questions and Answers on Good Manufacturing Practices Questions and Answers on Good Manufacturing Practices - Penicillin Drugs.

In a nutshell, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include:

• 21 CFR 211.42(d): Separation of facility and equipment
• 21 CFR 211.46(d): Separate air handling systems (HVAC)
• 21 CFR 211.176: Test for traces of penicillin where possible exposure exits.

Related Posts:
2009 FDA Orange Book Online - Brand New 29th Edition
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

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FDA Makes Zometa Inj Orange Book Decision

• GMP Online Training. FDA cGMP QSR GMP online training classes offered by SkillsPlus International Inc.

Updated Dec 17, 2020
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 Food and Drug Administration (FDA) has determined that ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zoledronic acid lyophilized powder for injection, 4-mg base/vial. The Federal Register published the FDA docket "Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (pdf)."

According to IP Pharma Doc's post, Zoledronic acid (ZOMETA) lyophilized powder for injection: USFDA confirmed that drug was not withdrawn due to safety issues, this decision will allow US FDA to approve ANDA's for the innovator's (Novartis) discontinued product (in May, 2003).

Kurt Karst posts an in-depth analysis and commentary related to the FDA decision, Attention Orange Book Junkies: FDA Petition Response Cements Orange Book Preface Therapeutic Equivalence Clarification.

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FDA Orange Book Online - Brand New Edition

• FDA GMP QSR cGMP Training - popular online training classes

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

- - - original post below - - -

You've been waiting for this. A brand new 29th edition, the 2009 FDA Orange Book Online. The products in this FDA Orange Book have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume, the 29th edition, is current through December 31, 2008.

According to the FDA, "This publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act."

Related Posts:
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

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Easy FDA Orange Book Search Widget

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 - - -

You can perform your FDA Orange Book searches on the FDA's site, or you can use this Search Orange Book Widget to conduct your searches using a single interface. No more switching back and forth between multiple web pages! I used the widget as is, at the link location above. Some of you more tech savvy folks might consider installing the widget. Here's what the widget creator says . . .

by viswanathaa
Created 10/28/08
With all search options conveniently under one window, this widget allows one to search the US FDA electronic orange book faster & from your own homepage.

Happy hunting!

Related Posts:
FDA Orange Book - Online
About The FDA Orange Book - Slide Deck (free)

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About The FDA Orange Book - Slide Deck (free)

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 - - -

If you use the FDA's Orange Book, or have an interest in generic drugs, exclusivity, and patents, then take a gander at this slide deck from an FDA CDER staff member, "The Orange Book (slide deck; free)." The slide deck covers . . .

• What is the Orange Book?
• What is exclusivity and how does it work?
• How is the Food and Drug Administration (FDA) involved with patent protection?

Related Posts:
FDA Orange Book - Online

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170 Diabetes Tips from the ADA

Updated July 13, 2020

You might also be interested in resources from the ADA.  Find what you need:
https://www.diabetes.org/resources

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Managing diabetes isn't easy. Now you can get the latest advice from the experts. What to Expect When You Have Diabetes helps you get through all your questions. The book is skewed towards type 2 diabetes, because this is the type most diabetics have. The book is formatted in a question and answer format for easy understanding. For example, "Is diabetes a dangerous disease? - Should I tell my boss and coworkers that I have diabetes?" This book is authored by The American Diabetes Association, the nation's leading voluntary health organization supporting diabetes research, information, and advocacy.

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