"GMP means something different when in different regions of the world."'via Blog this'
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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Upon completion of the program the participant will be able to:Free is good!
- Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials
- Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site
- Apply ICH and local regulations to specific research activities at the clinical site
"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'Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
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.
- Bioresearch Monitoring (BIMO)
[New! 7/25]
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
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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.
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
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Fatty 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.”Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
"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."
Woo-hoo! After a very long wait, Nizoral Shampoo is back on store shelves.
This class prepares plant personnel to participate in an FDA Inspection.Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
"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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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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