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 ?
Short-term data suggest that some of the new drugs increase rates of diabetes and heart disease and some older drugs promote movement and neurological disorders.
The FDA recently approved several new drugs, and several more are slated to be approved this year.
Some of the patients in the trials already had cross resistance to Prezista when the trial began (due to their extensive resistance to other protease inhibitors), and it got worse on the average, as they used the drug--showing the importance of having more than one active antiretroviral, instead of introducing new drugs one by one as they become available, and then often losing them to resistance.
In 1999, in response to these concerns, the European Medicines Agency (EMEA) began drafting guidance that outlined an environmental risk assessment procedure to accompany pharmaceutical companies' applications to market new drugs in Europe.
If the FDA seems to be getting overly picky, demanding more and more tests before approving a new drug, CEOs should remember that old medical advice: An ounce of prevention is worth a pound of cure.
The challenge for salvage therapy is to coordinate 2 or more such programs so that salvage patients have access to 2 or more new drugs at the same time.
Local physicians say the study reinforced their belief in proceeding with caution when considering new drugs.
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.
A fourth new drug which Wellcome is investigating is a protease inhibitor licensed from Vertex.
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).

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