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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