Monday, December 26, 2011

FDA ramps up role as safety sheriff

Updated Oct 10, 2017

The original link broke.

You might also be interested in:
ONLY IN THE WORLD-HERALD; FDA RAMPS UP ROLE AS SAFETY SHERIFF FOOD MANUFACTURERS AND FARMERS PREPARE

- -  the original post follows below  - -

FDA ramps up role as safety sheriff - Omaha.com:

"The federal Food Safety Modernization Act will result in numerous changes — some large, some small — for food manufacturers and farmers in 2012 and beyond as the Food and Drug Administration continues its slow, steady rollout of new regulations. During the new law's first year, little has changed other than sweeping educational efforts to prepare farmers and food manufacturers for ramped-up federal inspection efforts. The inspections will include more, and increasingly intense, reviews of food safety and health protocols. But for 2012 and beyond, companies are preparing for financial effects. Over the next five years, the FDA is planning to issue more than 50 new rules, add inspectors and ramp up oversight efforts to the tune of $1.4 billion."
'via Blog this'

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Saturday, December 24, 2011

Happy Holidays!

Wishing all of you a safe and heartfelt holiday!

 

Tuesday, December 20, 2011

2012 Predictions for Global Supply Chains

Supply Chain Matters Blog 2012 Predictions for Global Supply Chains- Part One | Supply Chain Matters:

"We will kick-off this series with the full listing of our ten predictions for the upcoming year.  In upcoming postings, we will provide the detailed thoughts supporting each prediction."
'via Blog this'

You might also be interested in:
Auditing: Internal and External Customers and Suppliers - training by SkillsPlus International Inc.

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Monday, December 19, 2011

2012 Crystal Ball Predicts a More Aggressive FDA

2012 Crystal Ball Predicts a More Aggressive FDA:

"According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. "
'via Blog this'

The article references:
The FDA Pathway to Global Product Safety and Quality

It's hard to believe 2011 is nearly over, and 2012 is around the corner.  Here's to future trends!

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Thursday, December 15, 2011

FDA Crackdown on Viagra-Like Supplements

FDA Crackdown on Viagra-Like Supplements - Video - Bloomberg:

"The discovery came during a Food and Drug Administration inspection that’s part of an expanding crackdown by the agency on the $28 billion supplement industry."
'via Blog this'

My gut sense tells me that this is just the tip of the iceberg, a problem of enforcement that the FDA will be hard pressed to wrap their arms around.
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Tuesday, December 13, 2011

FDA Update - HCG Diet Products Are Illegal

Consumer Updates; HCG Diet Products Are Illegal:

"The Food and Drug Administration (FDA) is advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight-loss products. They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores. "
'via Blog this'



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Monday, December 5, 2011

FDA-approved hangover pill

Cheers! FDA-approved hangover pill promises to take edge off holiday partying - NY Daily News:

"A new FDA-approved hangover cure has hit the market just in time for holiday party season."
'via Blog this'

This new product is called Blowfish:



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Wednesday, November 23, 2011

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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Tuesday, November 22, 2011

FDA Consumer Updates - Food Safety Tips for Healthy Holidays

FDA Consumer Updates; Food Safety Tips for Healthy Holidays:


"Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill.

Typical symptoms of foodborne illness are vomiting, diarrhea, and flu-like symptoms, which can start anywhere from hours to days after contaminated food or drinks are consumed.

The symptoms usually are not long-lasting in healthy people—a few hours or a few days—and usually go away without medical treatment. But foodborne illness can be severe and even life-threatening to anyone, especially those most at risk:
- older adults
- infants and young children
- pregnant women
- people with HIV/AIDS, cancer, or any condition that weakens their immune system
- people who take medicines that suppress the immune system; for example, some medicines for rheumatoid arthritis

Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home."

'via Blog this'
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FDA.gov Free Title 21 CFR Search Tool

Code of Federal Regulations, seen at the Mid-M...
Image via Wikipedia
CFR - Code of Federal Regulations Title 21:   'via Blog this'

The FDA.gov website makes this free search tool available.

It helps you to search within CFR - Code of Federal Regulations Title 21 - Food and Drugs: Parts 1 to 1499

Nice little search page.

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Monday, November 21, 2011

An Alternative To The Free Online GCP Training by Quintiles

Free Online GCP Training


Updated 4/10/2015:
The Quintiles GCP training is no longer available to the public for free.
I recently discovered a free, publicly accessible GCP training program that might be of interest to you: The Good Clinical Practice (GCP) course, offered by the National Drug Abuse Treatment Clinical Trials Network

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














= = =

Free Online GCP Training | Clinical Research Learning Blog:  'via Blog this'
Upon completion of the program the participant will be able to:
  1. Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials 
  2. Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site 
  3. Apply ICH and local regulations to specific research activities at the clinical site
Free is good!

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Quintiles is also a full sized CRO and has its operations over more than 40 countries world wide.  

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The Exemptee Institute
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Saturday, November 19, 2011

FDA withdraws approval of drug Avastin to treat breast cancer

FDA withdraws approval of drug Avastin to treat breast cancer - latimes.com:

"Studies showed that women with advanced breast cancer taking Avastin had a higher risk of death from stroke or heart attack, and that the medication raised blood pressure and increased the risk of congestive heart failure. The risk of serious bleeding was five times higher among users of Avastin than it was for those on chemotherapy only."  'via Blog this'
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Wednesday, November 16, 2011

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:
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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Tuesday, November 15, 2011

FDA Inspection Classification Database Search - Free

FDA Inspection Classification Database Search:   'via Blog this'

Wow! The FDA is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance.

In this inspections database, the FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.

Have a go at it!

You might be interested in:
Inspection Detection - an FDA cGMP training aid or game, focusing on 483 citations 

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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Monday, November 14, 2011

Seven Strategies for Avoiding a 483

Updated January 18, 2017

The link in the original post broke.

You might also be interested in:
In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI

- -  original post follows below  - -

Seven Strategies for Avoiding a 483:  'via Blog this'

"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."
A nice, quick and easy primer on 483s.

You might also be interested in:
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Wednesday, November 9, 2011

Fatty Foods Addictive as Cocaine

Updated May 14, 2017

The original article is no longer accessible for free.  You can get a brief overview of the article mentioned below, from this post:  Studies Show Junk Food as Addictive as Cocaine

- -  original post follows below  - -

Nora Volkow, director of the National Institut...Image via WikipediaFatty Foods Addictive as Cocaine in Growing Body of Science - Businessweek:  'via Blog this'

“The data is so overwhelming the field has to accept it,” said Nora Volkow, director of the National Institute on Drug Abuse. “We are finding tremendous overlap between drugs in the brain and food in the brain.”
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Tuesday, November 8, 2011

FDA Approves New Device - Screens for Melanoma

Title: Pathology: Patient: Melanoma: Asymmetry...
Image via Wikipedia
Updated 9/6/2013:
The original AP link below is broken. So here's a link to a similar article:
http://usatoday30.usatoday.com/news/health/story/2011-11-02/New-device-uses-light-to-screen-for-melanoma-detect-earlier/51040310/1

- - - - -

The Associated Press: New device uses light to screen for melanoma:    'via Blog this'

"The Food and Drug Administration (FDA) approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits."

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Monday, November 7, 2011

4 Health Behaviors 4 Longer Life - some alcohol

CDC Features - Four Specific Health Behaviors Contribute to a Longer Life: 'via Blog this'

To live healthier and longer, drink "some."  The key is "Drink alcohol in moderation (men should have no more than two drinks per day; and women no more than one drink per day)."

For more information:


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Saturday, November 5, 2011

Nizoral Shampoo Available Again - I'm thrilled!

Woo-hoo!  After a very long wait, Nizoral Shampoo is back on store shelves.



The manufacturer has been is blaming a switch in manufacturing facilities.

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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Thursday, November 3, 2011

FDA Awards Two New Regulatory Research Centers

Photograph of the Taxus drug-eluting stent, fr...Image via WikipediaFDA launches two centers to improve approval of drugs, devices - The Hill's Healthwatch:  'via Blog this'

"The Food and Drug Administration (FDA) on Wednesday awarded $2 million to support the creation of research centers tasked with improving the way new medicines and medical devices are reviewed and evaluated."

The centers will be established at the University of Maryland and Georgetown University.

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Wednesday, November 2, 2011

FDA Awards University Consortium To Improve Drug Manufacturing

Drug shortages: University of Maryland, other universities work to improve drug manufacturing process - baltimoresun.com:   'via Blog this'

The Food and Drug Administration (FDA) has given "a $35 million grant to" the National Institute for Pharmaceutical Technology and Education, a group of 11 universities, "to make the nation's drugs safer and less costly, and even produce more jobs, by improving the science of manufacturing."

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Our most popular course
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Monday, October 31, 2011

Should Mobile Medical Apps Require FDA Approval?

Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek:  ('via Blog this')

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek: ('via Blog this')

A nice pair of articles, fairly and delicately balancing how much is enough, versus too much FDA regulation.

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Tuesday, October 11, 2011

OK Folks, Get Walking! Huge Health Benefits

Kaiser Permanente leader touts the myriad benefits of walking.



So what are you waiting for?!

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Monday, October 10, 2011

FDA approves Cialis to treat benign prostatic hyperplasia

Updated April 16, 2017:

The original link broke. You might also be interested in:
Tadalafil (Cialis) - (on MedlinePlus)

- -  original post follows below  - -

Tadalafil tablet (20 mg)Image via WikipediaPress Announcements; FDA approves Cialis to treat benign prostatic hyperplasia:   'via Blog this'

'nuff said.

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Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
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Tuesday, October 4, 2011

Surviving FDA Enforcement Actions - Free Tips

Life in FDA’s fast lane | News | Packaging World:  'via Blog this'

In the article, LeeAnn Rogus offers many tips. Here's just one of the many pearls of wisdom that's shared:
"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."
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Wednesday, September 28, 2011

FDA Notes Primatene Mist Departure

Medical News: FDA Notes Primatene Mist Market Departure - in Product Alert, OTC from MedPage Today:     'via Blog this'

The only over-the-counter asthma inhaler sold in the United States will no longer be available next year as part of a phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs).

Epinephrine CFC inhalers, marketed as Primatene Mist, are being phased out because they use CFCs as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. 

Primatene Mist is approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma.

If you're a Primatene Mist user, the FDA recommends that you see a health care professional soon to get another medicine. A doctor, physician assistant, or nurse practitioner can all help you determine the best treatment option for you. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011.

From the FDA: Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011

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Tuesday, September 27, 2011

Securing Pharma Supply Chain - Senate HELP Committee Hearing - Videos

The Senate Health, Education, Labor and Pensions (HELP) Committee is examining the globalization of the pharmaceutical drug market and supply chain. Senators are seeking solutions for how to improve the FDA's inspection of foreign drugmakers and secure the drug supply chain - without adding too much to the agency's bottom line.

Here's a brief video snippet of the entire hearing. Senator Mike Enzi (R-Wyo.), Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee:


You can watch the entire hearing, Senate Committee on Health, Education, Labor and Pensions - Full Committee Hearing - Securing the Pharmaceutical Supply Chain - September 14, 2011 (video).  If you follow this link, you can access the text of the testimony given by each witness.  If you want a slightly larger video image, you can try watching:  C-SPAN - Committee Examines Foreign-made Pharmaceuticals - September 14, 2011 (video)

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Monday, September 26, 2011

Make GMP Training Effective - free tips

Allan Dewes. President of SkillsPlus Intl Inc.
Allan Dewes
President - SkillsPlus Intl Inc.
More food for your GMP training thoughts. Some free training tips.

Why GMP Training Does Seem To Work - SkillsPlus International Inc. Training Tips (pdf):  'via Blog this'

In a nutshell:
  • You must address poorly designed or delivered training.
  • It is essential that you align what's preached with what's practiced.
  • The organization must support and encourage GMP compliance in everything that they do.
For more information:

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