Drug GMP FDA-483 (observational) items:
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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.
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This class prepares plant personnel to participate in an FDA Inspection.Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
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"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testing and other methods, and raising public awareness of the dangers of substandard drugs."Previous Posts: FDA Draft Guidance on Anti-Counterfeiting FDA On Drug Counterfeiting FDA - Global Drug Supply Chain Needs Better Oversight
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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.
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Stay well!
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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
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!
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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).
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 “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.
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"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."
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