FDA's drug approval process is coming under fire

The Milwaukee Journal Sentinel;  March 27, 2000 ;     626 words ...FDA's drug approval process is coming under...idea that we are any easier on drug approvals," said Robert Temple, FDA's associate director for medical...and Manufacturers of America. The FDA accelerated its drug review process during the 1990s...

FDA Reapproves Bowel Drug After Pulling It for Safety; In Unprecedented...

The Washington Post;  June 8, 2002 ;     700+ words ......of serious side effects. The FDA withdrew the drug in 2000 after it was linked...deadly side effects. As the FDA has speeded its drug review process in recent years...Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Everyone...

Assessing the FDA via the Anomaly of Off-Label Drug Prescribing.

Independent Review;  June 22, 2000 ;     700+ words ......thought that the U.S. Food and Drug Administration (FDA) regulates the use of all...if it concludes that a new drug is unsafe or not effective, the FDA can decline to approve it...recall a previously approved drug. The FDA is the final authority on...

New Jersey: Drug Firms Say FDA Is Doing the Best It Can In Approving...

New Jersey Business;  June 1, 2003 ;     700+ words ......past January, the Food & Drug Administration (FDA) enacted a new provision to...each time it submits a New Drug Application (NDA). The FDA uses this money to hire more...recalled. The slow down of FDA drug approvals in 2000 may have...

FDA SEEKS MORE SAY ON DRUG LABELS REGULATORS WANT GREATER AUTHORITY TO...

The Boston Globe;  March 2, 2005 ;     622 words ......In February 2001, an FDA advisory panel recommended...warnings on the Vioxx drug label to reflect possible...In such a case, if a drug maker does not accept the FDA's warnings, the agency...said even without FDA authority to dictate drug label language, the...

Tension Around FDA Drug Approval

AP Online;  March 24, 2000 ;     700+ words ......03-24-2000 Tension Around FDA Drug Approval NEW YORK (AP...that we are any easier on drug approvals,'' said Dr. Robert Temple, FDA's associate director for...spokesman Jeff Trewhitt. The FDA accelerated its drug review process during...

FDA rejects expert panel recommendation, blocks OTC switch for Plan B...

The Guttmacher Report on Public Policy;  June 1, 2004 ;     700+ words ...The Food and Drug Administration (FDA) on May 6 overruled the recommendation...from typical. Normally, when the FDA evaluates a drug for safe OTC use, it looks at...under 16. Never before has the FDA approved a drug in the same dosage for the same...

LOTRONEX, PPA SHOW NEW FDA STYLE ON DRUG RISKS.(Brief Article)

Medical Marketing & Media;  December 1, 2000 ;     700+ words ......multiple sources of drug experience information. Where the FDA finds alternatives...alternatives for all of the drug's target population, the FDA consults closely with...officer who examined the drug before its approval. Naming FDA Office of Post-marketing...

Prescription drug recalls raise questions about FDA approval process

Courier-News (Elgin, IL);  March 25, 2000 ;     700+ words ...Prescription drug recalls raise questions about FDA approval process THE...we are any easier on drug approvals," said Dr. Robert Temple, FDA's associate director...spokesman Jeff Trewhitt. The FDA accelerated its drug-review process during...

Analysis: FDA and drug safety

Talk of the Nation (NPR);  November 10, 2004 ;     700+ words ......NPR) 11-10-2004 Analysis: FDA and drug safety Host: NEAL CONAN...Sciences will review the FDA's drug safety systems, and the...Congress investigating the FDA because they in retrospect approved the drug too quickly without enough...

FDA panel rejects new Merck drug

The Record (Bergen County, NJ);  April 13, 2007 ;     700+ words ......County, NJ) 04-13-2007 FDA panel rejects new Merck drug By ANDREW BRIDGES, THE...Arcoxia is the first drug of its class to go before the FDA for approval since Merck...pressure more than the older drug. Graham, the FDA drug safety expert, and other...

FDA Says It Approved The Wrong Drug Plant; Heparin Probe Sends Inspectors...

The Washington Post;  February 19, 2008 ;     700+ words ......than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including...director for compliance at the FDA's center for drug evaluation and research, said...Chinese firm that made a different drug. The FDA accepts pr

Analysis: Challenges facing the FDA in its monitoring of drug safety after...

NPR Weekend Edition - Sunday;  November 7, 2004 ;     700+ words ......drugs are safe doesn't end when the FDA approves a new drug. Once a drug goes on sale and is...PRAKASH: Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research, says the...examine the effectiveness of the FDA's drug safety s

Analysis: FDA seeks ways to catch prescription drug problems more quickly

NPR Morning Edition;  June 8, 2005 ;     700+ words ......06-08-2005 Analysis: FDA seeks ways to catch prescription drug problems more quickly...group working with the FDA to speed drug approval. He says other...Woodcock. Dr. WOODCOCK: The FDA could, theoretically, take the drug off the market, but that...

Consumers Accuse Maker of Hormone Replacement Therapy Drug Estratest of...

PR Newswire;  August 7, 2003 ;     700+ words ......been approved by the Food and Drug Administration (FDA) for that use. Further, the group...recently by the FDA -- but also is a FDA-approved drug for the treatment of vasomotor...disseminates to doctors imply that the drug is FDA-approved for treating vasomotor...