The FDA takes action against unapproved drugs.

The Tip of the Iceberg of Misleading Online Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

Kim’s overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most co...

Compassion vs Control: FDA Investigational-Drug Regulation

Victims of AIDS and other incurable diseases are denied access to potentially valuable experimental drugs by the U.S. Food and Drug Administration. Under the present law, no new drug or medical device can be sold until it has been approved as safe and effective" by the FDA. New-drug approval is an expensive process that routinely takes years to complete. Unapproved experimental products cannot ...

PW01-007 – Colchicine brand switching in FMF patients

Introduction In July of 2009 the U.S. Food and Drug Administration enacted new regulation of colchicine under the “Unapproved Drugs Program.” Like other old drugs that were on the market before the existence of the FDA, colchicine had never been subjected to FDA-required safety and efficacy trials. One company elected to put colchicine through the FDA’s approval protocol and when approval was g...

Unapproved uses of approved drugs: The physician, the package insert, and the FDA.

Purchasing pet drugs online: buyer beware.

1 / FDA Consume r Hea l t h In fo r ma t ion / U . S . F ood and D r ug Admin i s t r a t ion DECEMBER 14 , 2007 Some of the Internet sites that sell pet drugs represent legitimate, reputable pharmacies, says Martine Hartogensis, D.V.M., Promotion and Advertising Liaison for FDA’s Center for Veterinary Medicine (CVM). But others are fronts for unscrupulous businesses operating against the law. ...