Mesothelioma Awareness Day

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Mesothelioma Awareness Day is September 26th, according to the Mesothelioma Applied Research Foundation.

All supporters, volunteers and patients affected by the asbestos-related cancer mesothelioma will help recognize Mesothelioma Awareness Day this Sunday on September 26, 2010. To learn more about this awareness day, go to the Foundation's webpage, Mesothelioma Awareness Day.

More reading:  100 Questions & Answers About Mesothelioma, Second Edition

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FDA Guidance - Impact Resistant Lenses - Q and A

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Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. As you read through the guidance, you'll find quite a number of useful hyperlinks to additional information and references.

Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(h)). These devices are subject to applicable device regulations under Title 21, Code of Federal Regulations. Impact-resistant lenses reduce the number of eye injuries from eyeglasses and sunglasses. Glass lenses, plastic lenses, or laminated glass lenses can be made impact resistant by any method. However, lenses generally must be capable of withstanding the impact test described in 21 CFR 801.410. This guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, lens testing apparatus, record maintenance, and exemptions to testing.

This guidance is a revision of “Impact-Resistant Lenses: Questions and Answers (FDA 87-4002),” issued September 1987. This guidance updates answers to questions that industry and consumers frequently ask FDA about impact-resistant lenses and FDA regulation of eyewear. The revision reflects the exemption of sunglasses from the Premarket Notification (510(k)) requirement effective February 19, 1998 (21 CFR 886.5850(b)). The revised document also includes a more detailed discussion about lens blanks, semi-finished, finished, and plano lenses, as well as import procedures. The terms "eyeglasses" and "spectacles" are used interchangeably in this document.

Eyewear products regulated by FDA are commonplace in the daily lives of the vast majority of the general public. FDA believes that impact-resistant lenses are an essential component of the safe design of these devices.  The use of impact-resistant lenses in eyeglasses and sunglasses is addressed in 21 CFR 801.410.

For more information on this topic, contact the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) by phone at 1-800-638-2041, by fax at 301-847-8149, by e-mail at dsmica@fda.hhs.gov, or write to the following address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Communication, Education and Radiation Programs
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Ave.
WO66-4613
Silver Spring, Maryland 20993

#FDA #GMP #training #cGMP

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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

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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 Form 483 Search Tool

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Updated January 27, 2021

Links in the original post broke.

FDAzilla is now a part of Redica Systems (formerly Govzilla)

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 Inspection Observations - FDA.gov

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FDAzilla offers a specialized search tool that makes it possible to search for Form 483 observations issued by the FDA.

One possible use of the search tool is to get a listing of Form 483s issued to companies in a particular country, for example, the search results of form 483 observations issued to companies in India.  Just alter your search keywords to view different results.

Related reading:  Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

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Inspection Detection - a GMP training game by SkillsPlus Intl Inc.

An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.

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FDA - Safe Drug Use After Natural Disasters

Floods, fires, earthquakes, hurricanes, oh my.  The FDA provides recommendations on Safe Drug Use After a Natural Disaster. Here's what they cover:

Drugs Exposed to Excessive Heat, such as Fire
Drugs Exposed to Unsafe Water
Drugs that Need Refrigeration

For more information:
FDA - Natural Disaster Response
FDA - Hurricanes: Health and Safety

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GMP Success Tips For Dietary Supplements

Image via WikipediaHere's a short and sweet digestible tip sheet, from Chromadex, on how to successfully tackle the FDA GMPs for Dietary Supplements, Dietary Supplement cGMP Highlights and Tips for Success - Tech Tip 0014 (PDF) 

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10 Bad Things That Can Be Good For Your Health

I love this article I read on CNN.com, America's healthiest pleasures: 10 'vices' that are good for you. This means I get to do a bunch of things without feeling guilty, and get a health benefit too!

I especially like indulging in coffee, chocolate, wine, sleep.... hmm, I think I like almost all ten!

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Pine Nuts Can Ruin Your Taste Buds

Image via WikipediaIf you're a foodie, you'll want to learn more about Pine Mouth.  It turns out that eating pine nuts can adversely affect your taste buds, according to this blog post, Taste Buds Gone Bad From Pine Nuts.

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Drug Safety and Accountability Act of 2010

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Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Bennet's press release, Senate Introduces New Bill on Drug-Manufacturing Quality Standards, says:

The bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.

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FDA Urgent Egg Recall Due To Salmonella

Updated April 21, 2017

The original link didn't age well.  You might have been interested in this related link:
August 20, 2010: Related nationwide recall:
Eggs from Hillandale Farms may put consumers at risk for Salmonella.

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Wow! These eggs are everywhere.

Be warned that these potentially contaminated eggs have traveled all over the country, reports this FDA news release, URGENT Nationwide Egg Recall - Eggs in Their Shells May Put Consumers at Risk for Salmonella.

If you've got eggs in the fridge, you probably want to read this urgent FDA update.

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FDA Says Giving Bones To Dogs Is Unsafe

The FDA says don't give your dog a bone.  Here are 10 reasons why it’s a bad idea to give your dog a bone:

1. Broken teeth.
2. Mouth or tongue injuries.
3. Bone gets looped around your dog’s lower jaw.
4. Bone gets stuck in esophagus, the tube that food travels through to reach the stomach.
5. Bone gets stuck in windpipe.
6. Bone gets stuck in stomach.
7. Bone gets stuck in intestines and causes a blockage.
8. Constipation due to bone fragments.
9. Severe bleeding from the rectum.
10. Peritonitis.

Basically, all of these end up with a visit to a vet due to serious injury or death. For more details and explanations, read on:

FDA - No Bones About It: Bones are Unsafe for Your Dog


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FDA Drug Identification Service

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I was surprised to discover this service. According to the FDA Drug Identification webpage:

"Division staff can identify drugs for you based on physical appearance (color, shape, size, etc.) and markings. Email DDI your drug description at druginfo@.fda.hhs.gov. 

We will identify drugs for you as soon as possible. However, please note that this is not an emergency service. In the case of an emergency, please contact the Poison Control Center 1-800-222-1222."

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Be Vigilant - Drowning Is Silent

I was surprised to learn that people who are drowning are actually very quiet, and don't wave their arms above water, according to this Medical News Today article, Do You Know What Drowning Looks Like?

Bottomline, when things get very quiet, you must be vigilant. People drowning aren't likely to be able to shout or wave for help.

Have fun this Summer, be safe, and be vigilant.

More information:
CDC - Unintentional Drowning - Fact Sheet
Handbook on Drowning: Prevention, Rescue, Treatment

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FDA Orange Book - Most Current Versions

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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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FDA Advice On Medical Device and Hurricane Preparedness

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Hurricane season is here.

Follow these tips and you should be well on your way to disaster preparedness, FDA Offers Tips about Medical Devices and Hurricane Disasters.  

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