Wednesday, January 23, 2013

Booze Disrupts Sleep

Booze before bedtime may lead to bad sleep - CBS News:

"The research showed that people were able to fall asleep faster and displayed increases in slow-wave sleep (SWS) -- or deep sleep -- during the first half of the night. SWS consists of stage 3 and 4 of NREM sleep, periods when the body repairs and regenerates tissues, builds bone and muscle and is believed to strengthen the immune system. This is typically known as the rest and restoration part of the sleep.

However, people who drank more alcohol tended to have their sleep interrupted during the second half of the night. What's more, the REM sleep portion of their cycle was disturbed during sleep, including delays in first onset of REM sleep. "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 


Ben Venue Signs FDA Consent Decree Over Drug Manufacturing Problems

Updated October 19, 2020

The link in the original post broke.

You might also like:

- - -  original post follows below  - - -

Ben Venue Signs Consent Decree with FDA Over Drug Manufacturing Problems | Fox Business:

"Ben Venue Laboratories, the contract drug manufacturer whose quality lapses caused a shortage of Johnson & Johnson's (JNJ) cancer drug Doxil and recalls of numerous other drugs, reached an agreement with U.S. authorities governing the company's efforts to fix the problems.

Ben Venue, a Bedford, Ohio, division of Germany's Boehringer Ingelheim, signed a so-called "consent decree" with the Food and Drug Administration, according to a company statement and court documents filed by the Department of Justice in federal court in Ohio.

The consent decree bars Ben Venue from making and selling certain drugs until the company can demonstrate that it has taken certain steps to correct its manufacturing problems, among other requirements."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

Tuesday, January 22, 2013

FDA on Serving Up Safe Buffets

Some great food safety tips from the FDA, on how to serve a buffet when entertaining at home . . .

Consumers > Serving Up Safe Buffets:

"Entertaining is one of the mainstays of the holiday season – and helps commemorate milestone events throughout the year, too. With proper prep, you can be creative and tempt your party guests with an array of fun platters … while still keeping food safety in mind!

Plan a “bacteria–free buffet” with these helpful tips: . . ."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Friday, January 18, 2013

FDA - Pharma Warning Letters and Notice of Violation Letters

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:

"These letters are supplied by the CDER Freedom of  Information Office (FOI).  This page only covers letters issued by Headquarters and the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications).  For District Office warning letters, please see the Main FDA FOI Warning Letters Page.

Some of the letters have been redacted or edited to remove confidential information.  Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Exemptee Institute
The Designated Representative Institute
The Health, Drug, Prescription, and GMP Supersite Gift Store 


From SkillsPlus International Inc.