FDA to offer guidance on marketing drugs for unapproved uses

Capital (Annapolis);  February 17, 2008 ;     370 words ......companies can use medical journal articles to market drugs for unapproved...not been cleared by the FDA as safe and effective. However...for reprints of medical journal articles, which sales people often...Internal Medicine. Under FDA's proposal, posted online...come from a ...

FDA to guide drug companies on marketing 'off-label' uses

Charleston Gazette;  February 16, 2008 ;     299 words ......companies can use medical journal articles to market drugs for unapproved...not been cleared by the FDA as safe and effective. However...for reprints of medical journal articles, which salespeople often...Internal Medicine. Under the FDA's proposal, posted online...come from a ...

FDA faces court-ordered limits to its power.

Medical Marketing & Media;  September 1, 1997 ;     700+ words ......the safety and efficacy of FDA-approved drugs and devices inevitably outpaces FDA-approved labeling. In some...resorting to off-label uses. The FDA acknowledges the important...practices. But what the FDA has done is to go to great...of peer-reviewed medical journal articles that ...

FDA promotion rules under scrutiny

Pharmaceutical Executive;  September 1, 1998 ;     700+ words ...Questions arise over whether FDA should have the authority...new policy proposal from FDA are raising questions about...Lamberth. He ruled in July that FDA regulations that limit the dissemination of journal articles and textbooks and curb industry...The judge decided that FDA cannot ...

Lawmaker protests new FDA guideline

Charleston Gazette;  December 1, 2007 ;     515 words ......an exception for journal articles. That law recently...articles to the FDA before they sent...receipt of medical journal articles and medical or...guidelines said. The FDA guidelines said...to get medical journal articles to physicians because...published and when the ...

FDA would expand promotion.(Policy & Practice)

Pediatric News;  March 1, 2008 ;     203 words ......distribute medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical...under guidelines set by the FDA, but that authority expired in September 2006. The FDA's new Good Reprint Practices...

FDA seeks to allow wider use of drugs

International Herald Tribune;  February 18, 2008 ;     545 words ......Tribune 02-18-2008 FDA seeks to allow wider...with copies of medical journal articles that discuss product...or approved by the FDA. The rules also say...to hand out medical journal articles so that doctors can...Gottlieb, a former FDA deputy commissioner...America, said that ...

FDA would expand Promotion.(POLICY & PRACTICE)

Clinical Psychiatry News;  April 1, 2008 ;     150 words ...The FDA last month proposed guidance to let drug...makers distribute medical or scientific journal articles and reference publications on unapproved...materials under guidelines set by the FDA, but that authority expired in September 2006. The FDA's new Good Reprint Practices proposal...

Seven views of the WLF legal victory. (Washington Legal Foundation's suit...

Medical Marketing & Media;  September 1, 1998 ;     700+ words ......previously served as associate chief counsel for drugs at FDA). From the advertising community we received commentary...industry group that was formed in 1992 in reaction to the FDA's CME proposals. We also approached the FDA, the Pharmaceutical Research and Manufacturers of America...Bennett Partner ...

Judge Curbs FDA Role On `Off-Label' Therapy; Drug Firms More Free to Push...

The Washington Post;  July 29, 1999 ;     700+ words ......we have to do as a follow-up," said Peggy Dotzel, the FDA's acting associate commissioner for policy. But Dan Troy...Washington Legal Foundation, plaintiffs in the case against the FDA, called Lamberth's ruling "total vindication of our position." He said he expected the FDA to appeal. The foundation, a ...

FDA Draft Guidance on Industry Medical Publications

The Journal of Nuclear Medicine;  April 1, 2008 ;     381 words ......Food and Drug Administration (FDA) on February 15 issued draft...distribution of medical or scientific journal articles and reference publications...discuss unapproved uses of FDA-approved drugs and devices...care," said Randall Lutter, FDA deputy commissioner for policy...promotion." ...

Ease FDA's grip on uses for new drugs.

Insight on the News;  May 8, 1995 ;     695 words ......practice could save 10,000 American lives each year. Yet the FDA has prohibited such notices. And since no company has...satisfy the agency. Among the items being suppressed by the FDA's new policy are medical textbooks. Textbooks often discuss...use, including uses not yet ordained or approved by the ...

FDA yields - but is it enough?

Medical Marketing & Media;  January 1, 1996 ;     700+ words ...Two FDA draft guidances allow manufacturers to disseminate articles...breakthrough came in early December with the publication of an FDA policy notice announcing the availability of two draft...guidances. Everybody knows that although it's not supposed to, FDA frequently begins acting on draft documents ...

FDA to Back Food From Cloned Animals; Move Would Defy Congress's Wish for...

The Washington Post;  January 5, 2008 ;     700+ words ......version, contains stronger, binding language that would block FDA action on cloned food, probably for years. With a conference...finalize the farm bill in the next few weeks, that left the FDA a potentially narrow time frame within which to act if...because U.S. policy is technically still under review. The ...

FDA TO BACK FOOD FROM CLONED ANIMALS

Rachel's Democracy & Health News;  January 10, 2008 ;     700+ words ...HD FDA to Approve Food From Cloned Animals Move Would Defy Congress...contains stronger, binding language that would block FDA action on cloned food, probably for years. With a conference...finalize the farm bill in the next few weeks, that left the FDA a potentially narrow time frame within which to act ...