Drug GMP FDA-483 (observational) items:
Return Home: http://drughealth.blogspot.com/
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).
Previous Posts: Happy Thanksgiving - Celebrate These Food Safety Tips
Return Home: http://drughealth.blogspot.com/
I recommend you go to his post, and jump into the discussion. On some gut level, I'm hoping the predictions ring true as my retirement investments will benefit.
Previous Posts: Biotechnology Trends 2010 - Free Report
Return Home: http://drughealth.blogspot.com/
This class prepares plant personnel to participate in an FDA Inspection.Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
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.
Updated April 21, 2017
This post didn't age well. The video links have broken, so I've removed them from the original post.
You can get a sense of the video with this collection of photos:
PSAs Say No to Drugs
- - most of the original post follows below - -
I was catching up with news this wet Saturday morning and ran across this CBS News mini-history of anti-drug messaging over the years. Enjoy!
For related photos and links specific to this video clip go to CBS News PSAs Say No to Drugs Photos.
Previous Posts:
Sugar As Addictive As Cocaine Or Heroin
Epidemic Teen Addiction To Prescription Drugs (video)
Parents, Get A Clue About Teen Drug and Alcohol Abuse
Are Your Teens Abusing Drugs? - 4 Tips
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Previous Posts: Abzymes Pinpoint The HIV Achilles Heel 109 HIV Drugs And Vaccines Under Development Listen To People With AIDS and HIV (audio)
Return Home: http://drughealth.blogspot.com/
I just read a newspaper article reporting that users of http://www.bedbugregistry.com/ have been reporting the most complaints in Toronto and Vancouver. I checked out the "registry" and find it both fun and enlightening. Check it out!
Yep, the year is coming to a close. If 2009 snuck up on you and you still have some training needs, it's not too late. Arranging some onsite training might be challenging, but it's not too late to identify vendors that offer products and services that you can leverage. For example, buy some modules or materials, so that you can deliver training yourself. Or, locate vendors that offer online delivery of training via CBT (computer based training), so that you don't have to spend an arm and a leg to bring in a trainer on-site. The fastest way to find vendors who can help you, is to use www.google.com and search on "gmp training". 2009 is almost gone, and it's time to start planning your 2010 regulatory training plan.
Learn about the latest worldwide effort to fight substandard and counterfeit drugs, in this PharmTech Talk article, USP and USAID Launch New Program to Improve Drug Quality. In a nutshell, Alexis Pellek writes:
"The $35-million program, called Promoting the Quality of Medicines (PQM) will work to improve the safety of medicines in approximately 30 countries worldwide by working to strengthen regulatory bodies, increasing the supply of legitimate products, detecting and reducing availability of counterfeits through testing and other methods, and raising public awareness of the dangers of substandard drugs."Previous Posts: FDA Draft Guidance on Anti-Counterfeiting FDA On Drug Counterfeiting FDA - Global Drug Supply Chain Needs Better Oversight
Initially, I wasn't too thrilled about the FDA website getting re-designed. Now I'm starting to like what I'm seeing. For example, I'm seeing more user friendly pages like the CFR Search page. If you don't have the Search CFR Title 21 Database page bookmarked, you really should. It's a terrific database search tool for finding CFR contents by:
Return Home: http://drughealth.blogspot.com/
This Q & A article from PharmTech is an interesting read, Preventing counterfeits from entering the supply chain. I find it sobering that a small percentage of drugs are counterfeit, yet counterfeited drugs represent a growing and substantive volume of tampered, contaminated, diluted, substituted, adulterated, and misrepresented ingredients.
Here's more from the FDA's CDRH Learn treasure trove of free online courses. ... and these are in Mandarin Chinese! As of this posting, there's only one FDA CDRH Learn course in Mandarin, but you can expect more courses to be on their way. Here's what's available so far: Quality System Regulation 21 CFR Part 820 Basic Introduction Online Video Presentation Transcript
 |
| Our most popular course |
 |
| Put fun back into GMP training! |
The FDA announced today that it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:
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.
The site includes sections on:
This is of interest to me as I grow older, and my siblings are showing signs that they might benefit from these devices.
Return Home: http://drughealth.blogspot.com/
When thinking about throwing away medications, be sure to consider family, pet, and environmental safety. The FDA just released more information about how to dispose of certain medications, Disposal by Flushing of Certain Unused Medicines: What You Should Know. These certain medicines appear to be highly potent drugs with a high potential for abuse.
Return Home: http://drughealth.blogspot.com/
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.
This KWTX news article reports a hospital's problem with CT brain scan radiation overexposure, FDA Warns Hospitals About CT Brain Scan Radiation. The excessive dose problem was identified when a patient reported hair loss after a scan. The end result, the FDA has posted a notification, Safety Investigation of CT Brain Perfusion Scans: Initial Notification.
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:
Stay well!
Return Home: http://drughealth.blogspot.com/
Image via Wikipedia
Return Home: http://drughealth.blogspot.com/It still isn't easy to get an LSD study off the ground. Researchers must get permission from the U.S. Food and Drug Administration and the Drug Enforcement Administration plus state regulators, and they need approval from the institution they work for. Then they have to get approval for the source of the actual drug - in the case of UCSF, researchers are using LSD that was manufactured years ago in Switzerland.
The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
I ran across this information packed and thought provoking series about wine and your heart. It consists of 3 parts:
Ellen Mack, M.D., M.P.H., the author, says:
The first two parts (see Part 1 &Part 2) of the series Wine and your Heart examined some of the vast epidemiological and scientific evidence that moderate consumption of wine is associated with decreased cardiac mortality. Is this information being put to good use?
For me, this all means, drink a little to be healthy. Cheers!
Previous Posts: Men - Study Says Drink Wine and Live Longer Epidemiological Reasons To Drink Alcohol For Health Australian Wine Doctor Says Drink His Wine For Health
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) Return Home: http://drughealth.blogspot.com/ GMP Posters The Health, Drug, Prescription, and GMP Supersite Gift Store
Image via Wikipedia. . . nothing Sinclair wrote ever eclipsed the fame of his exposé, “The Jungle.” The 1906 novel was intended to spotlight dangerous and unfair working conditions in turn-of-the-century meat factories. Instead, it inspired a generation of vegetarians and a host of new food safety regulations, including one that ultimately led to the creation of the Food and Drug Administration(FDA).
According to the FDA's announcement, Warning Letter Close-Out Letter Program, the FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process, CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.
Date: October 15, 2009 Time: 8:00 a.m. - 5:00 p.m.
Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102. There is no registration fee Space is limited to 225 participants. The FDA appreciates advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis.Return Home: http://drughealth.blogspot.com/Now, however, FDA “will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued,” according to an announcement in the Federal Register.
The U.S. Food and Drug Administration has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site. The changes on the Web page are as follows:
The “Warning Letters” page can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. The FDA will continue to look for ways to improve the “Warning Letters” webpage in the future.
Previous Posts: Food Industry Ramifications of the FDA Cheerios Warning Letter FDA Warning Letter - Space Shuttle Fruitcake
Return Home: http://drughealth.blogspot.com/
Sarah Sunday writes this excellent legal opinion explaining the background and ramifications of the FDA's warning letter to the makers of Cheerios, Is FDA Warning Letter An Ominous Signal To Food Industry? This is all about the FDA objecting to the statement that Cheerios can lower cholesterol levels. In a nutshell, she says:
"FDA's Warning Letter is a slap on the wrist in terms of the potential regulatory consequences. However, the letter could have a significant legitimizing effect on the pending California lawsuit, and in that way, could have costly implications for both General Mills and the food industry as a whole."
Previous Posts: And The Top 10 Food Stories Of 2008 Pet Food Sickened People - Did they eat it? . . . Time To Talk About Turkey Cooking and Food Safety FDA CFSAN - Food Safety and Nutrition Video Library (free)
Return Home: http://drughealth.blogspot.com/
Posts
All Comments
