References in periodicals archive ?
If finalized, the guidance could call for substantially more testing of new drugs than has been demanded thus far.
Furthermore, there will always be people who need access to multiple new drugs prior to the launch of EA programs.
The JAMA study noted that new drugs are heavily marketed to both doctors and consumers, which means they may be in wide distribution before adverse effects are known.
With the fee set at about $310,000 (in 2001) for each new-drug application and strong market demand for innovative new drugs, there is much at stake in the debate over the program's reauthorization.
As a result of the new drugs, Bailey-Boushay House in Seattle, a SNF dedicated to AIDS care, now has beds available for other types of medically complex patients.
The simple message is that all new drugs should be used judiciously in the patients most likely to benefit.
Marketing expertise" seems like a slender reed to justify this deal, since a promising new drug does not exactly require a hard sell, like a new brand of perfume.
For any disease, a basic understanding of the underlying disease process must be obtained so that new drug development can proceed against a background of a strong scientific rationale.
SPD754 is under Investigational New Drug status and has received fast-track approval from the US-Food and Drug Administration.
Field insiders expect microarray data will eventually be a standard component of submissions for both investigational new drug applications (for use in clinical tests) and new drug applications (for marketing new drugs in the United States).
It offered mechanisms for making a new drug available to people in need at the first sign that it was effective and seemed reasonably safe.

Full browser ?