new drug


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new drug

a drug for which the U.S. Food and Drug Administration requires premarketing approval.

new drug

Any agent intended for therapeutic use in man, the composition of which is not generally recognised (among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs) as safe and effective for use under the conditions prescribed, recommended or suggested in the labelling.

new drug

Clinical pharmacology Any agent intended for use in man, the composition of which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. See Investigational new drug.

new drug

A drug for which premarketing approval is required by the Food, Drug and Cosmetic Act (a U.S. law granting authority to the FDA to oversee the safety of food, drugs, and cosmetics).
See also: drug

Patient discussion about new drug

Q. is it ok to use drugs for medical reasons? and who is to decide when is necessary to use drugs when needed?

A. Today the most used "medical" drugs are narcotics- for pain relief, for patients who suffer extreme pain. All sorts of Codaine and Morphine types are used and on a very wide basis, and they are specially perscribed for ones who need them.

Q. How about Psychiatric Drugs for bipolar? One of my friend is suffering from bipolar. Will Psychiatric medications help him to come out of this affect?

A. from what i read- there are certain medication that can help. if the first one doesn't - there is a second and third line of medication. from a personal experience (not mine, a friend of the family) it can even save your friend's life..

Q. What medications are forbidden to take with alcohol? And why is that?

A. I think this web page will give you something to think about:
http://pubs.niaaa.nih.gov/publications/aa27.htm
apparently there are more drugs you shouldn’t mix with alcohol then I could think of…

More discussions about new drug
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.

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