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Clinical Research Solutions
If your company has used Cetero Research's Houston facility to conduct bioanalytical studies between April 1, 2005 and June 15, 2010, your marketing applications may need to be repeated or confirmed....
Clinical Research Solutions
Although it is widely known that the acronym GRAS stands for “Generally Recognized as Safe”, many individuals believe that GRAS substances have been rigorously reviewed for safety and approved for...
Clinical Research Solutions
Did you know that the FDA Rulemaking Process allows for the public to comment before procedural and scientific requirements go into effect? This is the case for both the debut and amendments to...
Clinical Research Solutions
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
Clinical Research Solutions
In a recent teleconference with senior officials in the Office of Generic Drugs (OGD) at the FDA, it was conveyed that it is the policy of OGD in determining the safety of excipients to rely...
Clinical Research Solutions
We all know that the FDA’s mission is to promote and protect public health. However, in their effort to protect the public health, it seems that they may be inadvertently harming the industry that...
Clinical Research Solutions
It has become common practice in developing drug formulations to consult the FDA's Inactive Ingredient Guide (IIG) to obtain information on "acceptable levels" of excipients used in previously...
Clinical Research Solutions
The regulations developed by the FDA for implementing the Orphan Drug Act contain a number of features that are intended to maximize benefits to the orphan disease patient population, but which pose...