Regulatory Affairs Syndicator

Medscape News - October 24, 2006 — The US Food and Drug Administration has modified iPLEDGE, the risk management program for the acne drug isotretinoin ( Accutane ), by eliminating a requirement that has caused consternation among patients, dermatologists, and …

NewsNet 5 - The allergy community continues to work with the Food and Drug Administration to improve product labeling,” said Dr. Rebecca Gruchalla, chief of allergy at the University of Texas Southwestern Medical Center at Dallas. “However, while labeling is …

Denver Post - Food and Drug Administration said it needed more clinical studies for all indications, the statements said. Forest, based in New York, wants to develop new drugs to reduce reliance on two drugs that accounted for 80 percent of its $2.96 billion in …

Syracuse Post-Standard - LOUISVILLE, Colo. and NEW YORK, Oct. 23 /PRNewswire-FirstCall/ — Replidyne, Inc. (Nasdaq: RDYN ) and Forest Laboratories, Inc. (NYSE: FRX ), reported today the U.S. Food and Drug Administration (FDA) has issued a non- approvable letter for Replidyne …

MSN MoneyCentral - LOUISVILLE, Colo. and NEW YORK, Oct. 23 /PRNewswire-FirstCall/ — Replidyne, Inc. RDYN and Forest Laboratories, Inc. FRX , reported today the U.S. Food and Drug Administration (FDA) has issued a non- approvable letter for Replidyne’s new drug …

Centre Daily - Food and Drug Administration approved Xigris in 2001, despite an evenly split vote by its advisory committee. The lead author of Thursday’s journal article, Dr. Peter Q. Eichacker, voted against approval as an adviser. The other two authors are Dr …

Daily News-Record - The Food and Drug Administration approved the vaccine four months ago. Now Merck and Co. needs approval to manufacture the vaccine at its 12,000 square-foot expansion completed last month. Gardasil is a vaccine that targets HPV – the most common …

WLNS - WEDNESDAY, July 12 (HealthDay News) — The first once-a-day combination drug treatment for people with HIV/AIDS gained approval Wednesday from the U.S. Food and Drug Administration and will soon be available to patients. The drug, called Atripla …

WLNS - WEDNESDAY, July 12 (HealthDay News) — The first once-a-day combination drug treatment for people with HIV/AIDS gained approval Wednesday from the U.S. Food and Drug Administration and will soon be available to patients. The drug, called Atripla …

WLNS - THURSDAY, Oct. 19 (HealthDay News) — The breakthrough cancer drug Gleevec will now carry a new “precaution” on its label about possible severe congestive heart failure as a result of its use. The announcement came Thursday from the U.S. Food and …

Argus Leader - He follows the April pronouncement from the Food and Drug Administration that smoked marijuana had no accepted medical use. Remember, FDA folks are partially funded by drug companies. They’re the ones who gave us Vioxx and kept secret research …

WATE - Food and Drug Administration (FDA) regulates vitamin and mineral dietary supplements as a food product. The United States Pharmacopeia (USP) created the Dietary Supplement Verification Program (DSVP) to help consumers be sure that what is on the …

KXAN - WEDNESDAY, July 12 (HealthDay News) — The first once-a-day combination drug treatment for people with HIV/AIDS gained approval Wednesday from the U.S. Food and Drug Administration and will soon be available to patients. The drug, called Atripla …

KXAN - Food and Drug Administration. By contrast, the number of investigators working on FDA-approved trials overseas rose by 8 percent, suggesting an increase in outsourcing of drug research to cheaper sites abroad, the Post said. The declines in U.S. trials …

Columbus Business Journal - Under the plea agreement, Albers admitted that he had sold counterfeit and misbranded Neupogen to a California firm in September 2001, despite warnings and notices from the Food and Drug Administration and his own knowledge of counterfeit Neupogen …