FDA may require more long-term data to approve psychiatric drugs.

The U.S. Food and Drug Administration is considering requiring manufacturers of psychiatric medications This is an alphabetical list of psychiatric medications used by psychiatrists to treat mental illness or distress.

Please note:

The list is not exhaustive.
Names in italics are brand-names.
Not all drugs listed are used regularly in all countries.

to perform longer-term studies of the drugs' ability to address chronic conditions and to submit data from such studies before the agency will grant approval to market the treatments in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. .

The FDA's Psychopharmacologic Drugs Advisory Committee met on Oct. 25, 2005, to discuss whether longer-term data are needed and, if so, how studies could best be designed to elicit e·lic·it
tr.v. e·lic·it·ed, e·lic·it·ing, e·lic·its
1.
a. To bring or draw out (something latent); educe.

b. To arrive at (a truth, for example) by logic.

2. such information. Specifically, the committee considered these questions:

1. Is it a reasonable expectation that a drug manufacturer would have accumulated ac·cu·mu·late
v. ac·cu·mu·lat·ed, ac·cu·mu·lat·ing, ac·cu·mu·lates

v.tr.
To gather or pile up; amass. See Synonyms at gather.

v.intr.
To mount up; increase. data for both acute and longer-term efficacy trials at the time of filing an application for a drug?

2. If the answer to question #1 is yes, is it reasonable to expect that the manufacturer must have demonstrated both acute and longer-term efficacy?

The FDA FDA
abbr.
Food and Drug Administration

FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration. typically requires that only brief studies, often lasting three months or less, be conducted before submitting an application for marketing approval. After drugs are released for consumption, manufacturers usually complete longer-term research, such as conducting "withdrawal" studies to determine whether patients will re-exhibit symptoms of their condition after they stop taking a drug.

For more information, visit www.fda.gov.

Leadership Behaviors and Gender Stereotypes

Feminine Behaviors

"Taking Care"

Supporting

Rewarding

Mentoring

Networking

Consulting

Building Teams

Inspiring

Masculine MASCULINE. That which belongs to the male sex.
2. The masculine sometimes includes the feminine, vide an example under the article Man, and see also the articles Gender, Worthiest of blood; Poth. Intr. au titre 16, des Testamens et Donations Testamentaires, n. Behaviors

"Taking Charge"

Solving Problems

Delegating

Influencing Superiors

SOURCE: Catalyst 2005

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Title Annotation:	Food and Drug Administration
Publication:	The Journal of Employee Assistance
Article Type:	Brief Article
Geographic Code:	1USA
Date:	Jan 1, 2006
Words:	231
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