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Unapproved Drugs Initiative
'''Unapproved Drugs Initiative (UDI)''' is a program initiated by the [[United States Foo ...acturing quality. The initiative seeks to identify and take action against unapproved drugs that could be unsafe, ineffective, or of poor quality.

3 KB (427 words) - 17:17, 26 March 2024

Page text matches

Ide
Investigational device exemption, the license to test an unapproved new medical device

138 bytes (15 words) - 11:55, 8 April 2024
Ind
Investigational new drug; the license to test an unapproved new drug

120 bytes (14 words) - 04:43, 7 April 2024
Unapproved Drugs Initiative
'''Unapproved Drugs Initiative (UDI)''' is a program initiated by the [[United States Foo ...acturing quality. The initiative seeks to identify and take action against unapproved drugs that could be unsafe, ineffective, or of poor quality.

3 KB (427 words) - 17:17, 26 March 2024
Emergency use authorization
...(FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, t

1 KB (175 words) - 15:07, 10 November 2020
Off-label use
...prescribing [[pharmaceutical drugs]] for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and

1 KB (206 words) - 05:11, 4 March 2024
Marketing of off-label use
...he promotion of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both in the United States an ...ical companies have been fined billions of dollars for promoting drugs for unapproved uses, often without sufficient evidence of safety or efficacy.

3 KB (366 words) - 03:27, 30 March 2024
Off label
...' is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and

2 KB (235 words) - 21:03, 24 February 2024
Off-label
...ctice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and

2 KB (267 words) - 00:19, 24 February 2024
Dienedione
...ts that were seized during FDA enforcement of Bodybuilding.com for selling unapproved new drugs. The actual active metabolite, dienolone, is almost identical<br>

884 bytes (129 words) - 04:43, 8 April 2024
Emergency Use Authorization
...law allows the FDA to authorize the use of unapproved medical products or unapproved uses of approved medical products during a declared emergency, when there a

3 KB (377 words) - 21:38, 10 March 2024
Kurt Donsbach
...rges related to the practice of medicine without a license and the sale of unapproved drugs. ...the years, including practicing medicine without a license and the sale of unapproved drugs. In 2009, Donsbach was arrested in San Diego on charges including pra

3 KB (410 words) - 20:16, 23 April 2024
List Of Off-label Promotion Pharmaceutical Settlements
...ncluding the antidepressant Paxil and the diabetes medication Avandia, for unapproved uses. This settlement also included allegations of failing to report safety ...ations of kickbacks to physicians and pharmacists to promote the drugs for unapproved uses.

4 KB (481 words) - 17:08, 13 March 2024
Fotemustine
...opean medical community for its therapeutic potential, although it remains unapproved by the [[United States Food and Drug Administration|U.S. FDA]]. While fotemustine has found its place in the European market, it remains unapproved by the U.S. FDA. This divergence in regulatory status underscores the impor

4 KB (455 words) - 02:35, 27 September 2023
Fluorenol
[[Category:Unapproved drugs]]

1 KB (197 words) - 21:40, 25 February 2024
MyTomorrows
...nd their families, while others question the ethics of providing access to unapproved treatments.

2 KB (201 words) - 04:21, 22 February 2024
Gerovital
...he United States, the FDA bans Gerovital H3 from interstate commerce as an unapproved drug and, since 1982, has prohibited its importation. ...alth claims for Gerovital have been substantiated, and FDA considers it an unapproved new drug. It has caused low blood pressure, respiratory difficulties, and c

6 KB (908 words) - 08:30, 21 September 2019
Fasoracetam
[[Category:Unapproved drugs]]

2 KB (305 words) - 04:09, 6 March 2024
Expanded access
'''Expanded access''' or '''compassionate use''' is the use of an unapproved drug or medical device under special forms of investigational new drug appl

2 KB (344 words) - 03:02, 23 February 2024
Edivoxetine
[[Category:Unapproved drugs]]

3 KB (367 words) - 08:08, 22 March 2024
LGD-2226
...should be aware of the legal implications and health risks associated with unapproved substances.

3 KB (379 words) - 13:45, 20 April 2024