FDA And Others To Study Lasik Problems

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After having a conversation about Lasik complications with a co-worker, I thought I'd share this article with you, from the LA Times, Three federal agencies to assess potential Lasik problems. As much as I'd like to get Lasik corrected vision, I'm very reticent to do so. My co-worker has looked into this matter for herself, and she tells me that the 2% complication rate is the best possible scenario. This low rate in part is due to: the usage of the best equipment, and the procedure being performed at the hands of a well-trained practitioner who's completed many thousands of procedures. As for me, even a 2% complication rate is too much risk for me. How about you? 

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FDA Says Yes to IV Peramivir To Treat Flu

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:

• the patient is not responding to either oral or inhaled antiviral therapy, or
• when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
• for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.

I've been following this drug for sometime now, and I'm glad to see that it's found a niche during this flu pandemic. Additional Related Information From The FDA: EUA Letter of Authorization EUA Fact Sheet for Health Care Providers EUA Fact Sheet for Patients and Parents/Caregivers Information for Healthcare Professionals Sheet (HCP) on mandatory adverse event reporting for emergency use of peramivir under EUA 

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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IMS Predicts Pharma Growth in 2010

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

I can hardly believe 2009 is almost over. It's time to start looking ahead to 2010 trends. I caught this article on Pharmaceutical-ManufacturingNews.com, IMS Forecasts Global Pharmaceutical Market Growth Of 4 - 6% In 2010. IMS Health forecasts 4-6% growth in 2010, and 4-7% through 2013. 

Previous Posts: 2009 Pharmaceutical Trends 

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Obese To Pay More For Health Insurance - Controversy (video)

Updated July 12, 2021

The original link/video is no longer available.

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Adult Obesity Causes & Consequences - CDC.gov

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Wow! What a lightning-rod this can become. Lifestyle choices and health conditions driving potential increases in health insurance coverage costs. Watch this MSNBC news video, as it discusses North Carolina's intention to make state workers who are morbidly obese, pay more for their health insurance, Should weight impact your health costs?

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FDA Search Widget of Fraudulent H1N1 Products

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Updated March 10, 2022

The original links are no longer available.

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Protect Your Family From Fraudulent Flu Products - FDA.gov

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H1N1 Fraudulent Products

This FDA widget helps you find out if a product you're interested in is legitimate or a fake.
I commute on public transportation every day. We're in the height of cold and flu season. I'm not likely to try any of these products, but if you're interested, check them out before you buy them. Let the buyer beware!

Launch FDA widget:
H1N1 Fraudulent Products

Previous Posts:
Got Wine Flu?
Flu.gov Updated by HHS - New Resources Added
FDA Posts Current Flu Info and Resources
Swine Flu Increases Demand For Masks (video)
Treat The Flu With Red Wine?!

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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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FDA Says Flush Certain Medications

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. 

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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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Recent HIV Vaccine Study Results - Could be disappointing

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Updated January 14, 2024

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HIV vaccine research ‘at a crossroads’ after recent failures - Healio

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Optimism generated from a recent HIV vaccine study conducted by the US Army & Thailand, might not be justified after all, reports this Wall Street Journal article, Data Call Into Question HIV Study Results. The statistical analysis is discussed, and calls into question the conclusions reached and recently publicized. I think there's more to come on this. 

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FDA Warns of CT Scan Radiation Overdoses

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. 

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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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FDA Guidance - Device Registration and Listing Requirements

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

Updated January 27, 2021

The links in the original post broke.

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Device Registration and Listing - FDA.gov

- - -  original post follows below  - - -

The Food and Drug Administration (FDA) announced the availability of the guidance entitled "Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.'' The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. The guidance also describes the information that owner/operators of device establishments must submit to register their establishments and list their devices electronically, using FDA Form No. 3673. Those owner/operators seeking a waiver from the electronic submission requirement must submit their requests in writing to FDA with a complete explanation of why their registration and listing information cannot reasonably be submitted electronically. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). 

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Research Suggests Green Tea Promotes Weight Loss

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This just in, Effects of Catechin Enriched Green Tea on Body Composition.

In a nutshell:

• New research from China has found that regular consumption of green tea - which is rich in naturally-occurring tea actives called catechins - can significantly and positively effect body composition in moderately overweight individuals.
• The authors concluded that regular consumption of green tea with very high catechin content can, over a 90-day period, significantly reduce body weight, body fat mass and waist size in moderately overweight Chinese individuals.

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LSD Research Returns - FDA and Regulatory Oversight

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What a surprise to read this fascinating San Francisco Chronical article, LSD's long, strange trip back into the lab. According to the article:

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.

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