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.

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

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References in periodicals archive

The new drug approvals of 1996, 1997, and 1998: Drug development trends in the user fee era.

Nuevos medicamentos en Brasil: ?responden a las necesidades de la salud publica brasilena?

If finalized, the guidance could call for substantially more testing of new drugs than has been demanded thus far.

Damming the flow of drugs into drinking water

* 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.

What's wrong with the FDA? Either too fast or too slow, the agency can't find the right balance

'The new drug is only licensed in the UK for advanced stages of the disease.'

NEW HOPE?

The majority of new drugs are based on findings made by dedicated, hard-working, federally funded scientists in universities and government laboratories, not the research arms of drug companies.

Plunder drugs: why Americans believe they have to put up with pharmaceutical profiteering

Himmel said this approach overestimates the delay between marketing a new drug and labeling changes.

Adverse reactions after approval in 10% of drugs. (FDA Standards Questioned)

DELAY IN THE APPROVAL OF NEW drugs has been a policy problem in the United States since the mid-1970s.

How have user fees affected the FDA? The 1992 FDA reform successfully reduced drug review times. (Health & Medicine)

A NEW drug was revealed yesterday which offers male prostate cancer sufferers an alternative to drastic surgery.

New hope for cancer patients

So far, the new drug arsenal has changed the landscape of AIDS care.

HIV's potent cocktail

The traditionally tedious and lengthy process of reviewing new drug applications (NDAs) is undergoing a sea change at the Food and Drug Administration (FDA).

FDA SPEEDS REVIEW OF NEW DRUG APPLICATIONS WITH ADOBE ACROBAT AND PDF

[para] filing of an Investigative New Drug Application (INDA) with the Food and Drug Administration, along with all required documentation;

Looting the medicine chest: how Bristol-Myers Squibb made off with the public's cancer research

The four cases range from a change in the unit size in which a drug is available (e.g., the number of pills in a prescription) to a new drug.

What does the Consumer Price Index for prescription drugs really measure?